379 results on '"Lintzeris N"'
Search Results
102. Effects of pharmacotherapies for opioid dependence on participants' criminal behaviour and expenditure on illicit drugs: An Australian national evaluation (NEPOD)
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Nicholas Lintzeris, Erol Digiusto, Jason M. White, Alison Ritter, Richard P. Mattick, Jimmy D. Bell, John B. Saunders, Anthony Shakeshaft, Digiusto, E, Shakeshaft, A, Ritter, Alison, Mattick, RP, White, Jason Mark, Lintzeris, N, Bell, J, and Saunders, J
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medicine.medical_specialty ,Criminal behaviour ,Social Psychology ,business.industry ,050901 criminology ,05 social sciences ,050401 social sciences methods ,social sciences ,Naltrexone ,Pathology and Forensic Medicine ,Heroin ,Pharmacotherapy ,0504 sociology ,Property crime ,Opioid ,mental disorders ,medicine ,0509 other social sciences ,Psychiatry ,business ,Law ,health care economics and organizations ,medicine.drug ,Methadone ,Buprenorphine - Abstract
Data regarding criminal behaviour and expenditure on illicit drugs by 300 methadone patients and 997 heroin users who participated in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD) were analysed to measure the effects of pharmacotherapy and to identify predictor variables. At baseline, more heroin users than methadone patients reported recent involvement in any crime (39%, 13% respectively), and in each of four subtypes of crime (property, drug dealing, fraud, violence). Heroin users spent more on heroin than methadone patients (means of $3148, $617 in the past month, respectively). Younger age at first use of heroin was associated with higher reported levels of all four crime types, males reported more drug dealing and violent crime than females, lower employment status was associated with more property crime and drug dealing, lower educational status was associated with more property crime, and younger participants reported more violent crime. For participants who were heroin users at baseline and who were still in treatment at 3 months, mean monthly expenditure on heroin dropped from $2345 to $230. Involvement in any crime dropped from 39% to 20%, and also dropped in three of the four crime subtypes. There were no significant differences between the effects of methadone, buprenorphine, LAAM, and naltrexone treatment on criminal behaviour or expenditure on most types of illicit drug, although the pharmacotherapies did differ in terms of their effects on heroin expenditure. Improving treatment retention and expanding treatment availability to increase participation by heroin users would be likely to reduce drug-related crime, and would be a good social investment.
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- 2006
103. Short-term outcomes of five heroin detoxification methods in the Australian NEPOD Project
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Jo Kimber, Robert Ali, Richard P. Mattick, John B. Saunders, Nicholas Lintzeris, Erol Digiusto, Jimmy D. Bell, Courtney Breen, White, Jason Mark, Digiusto, E, Lintzeris, N, Breen, C, Kimber, J, Mattick, R.P, Bell, J, Ali, Robert, and Saunders, J
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Sedation ,media_common.quotation_subject ,Narcotic Antagonists ,Medicine (miscellaneous) ,Toxicology ,Heroin ,Ambulatory care ,Naloxone ,Internal medicine ,Detoxification ,medicine ,Ambulatory Care ,Psychology ,Humans ,Hypnotics and Sedatives ,Anesthesia ,media_common ,business.industry ,Heroin Dependence ,Pharmacology and Pharmaceutical Sciences ,Abstinence ,Middle Aged ,Naltrexone ,Buprenorphine ,Analgesics, Opioid ,Hospitalization ,Psychiatry and Mental health ,Clinical Psychology ,Treatment Outcome ,Inactivation, Metabolic ,Female ,medicine.symptom ,business ,Methadone ,medicine.drug - Abstract
This study included 380 participants in five heroin detoxification trials whose data were pooled to enable direct comparison of five detoxification methods in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Rapid detoxification achieved similar initial abstinence rates with either anaesthesia or sedation (average 59%), which were higher than was achieved by inpatient detoxification using clonidine plus other symptomatic medications (24%), which in turn was higher than outpatient detoxification using either buprenorphine (12%) or clonidine plus other symptomatic medications (4%). Older participants and those using more illicit drugs were more likely to achieve abstinence. Entry rates into ongoing postdetoxification treatment were as follows: buprenorphine outpatient (65%), sedation (63%), anaesthesia (42%), symptomatic outpatient (27%), and symptomatic inpatient (12%). Postdetoxification treatment with buprenorphine or methadone was preferred over naltrexone. Participants with more previous detoxification attempts were more likely to enter postdetoxification treatment. Given that outpatient detoxification was more effective with buprenorphine than with symptomatic medications and that rapid detoxification was more effective than the symptomatic inpatient method, the roles of the symptomatic methods should be reconsidered.
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- 2005
104. A cost-effectiveness analysis of heroin detoxification methods in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD)
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Robert Ali, Nicholas Lintzeris, Stuart Gilmour, John B. Saunders, Erol Digiusto, Marian Shanahan, Richard P. Mattick, Jason M. White, Christopher M. Doran, Jimmy D. Bell, Shanahan, MD, Doran, Chris, Digiusto, E, Bell, J, Lintzeris, N, White, Jason Mark, Ali, Robert, Saunders, J, Mattick, RP, and Gilmour, S
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Adult ,Male ,medicine.medical_specialty ,media_common.quotation_subject ,Cost-Benefit Analysis ,Narcotic Antagonists ,Medicine (miscellaneous) ,Toxicology ,Naltrexone ,Heroin ,Detoxification ,mental disorders ,Medicine ,Psychology ,Humans ,Hypnotics and Sedatives ,Psychiatry ,media_common ,Analysis of Variance ,Chi-Square Distribution ,business.industry ,Heroin Dependence ,Cost-effectiveness analysis ,Abstinence ,Buprenorphine ,Analgesics, Opioid ,Psychiatry and Mental health ,Clinical Psychology ,Opioid ,Emergency medicine ,Economic evaluation ,Female ,business ,Methadone ,medicine.drug - Abstract
This economic evaluation was part of the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD) project. Data from four trials of heroin detoxification methods, involving 365 participants, were pooled to enable a comprehensive comparison of the cost-effectiveness of five inpatient and outpatient detoxification methods. This study took the perspective of the treatment provider in assessing resource use and costs. Two short-term outcome measures were used-achievement of an initial 7-day period of abstinence, and entry into ongoing post-detoxification treatment. The mean costs of the various detoxification methods ranged widely, from AUD 491 dollars(buprenorphine-based outpatient); to AUD 605 dollars for conventional outpatient; AUD 1404 dollars for conventional inpatient; AUD 1990 dollars for rapid detoxification under sedation; and to AUD 2689 dollars for anaesthesia per episode. An incremental cost-effectiveness analysis was carried out using conventional outpatient detoxification as the base comparator. The buprenorphine-based outpatient detoxification method was found to be the most cost-effective method overall, and rapid opioid detoxification under sedation was the most cost-effective inpatient method.
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- 2004
105. Methadone-Buprenorphine Transfers Using Low Dosing of Buprenorphine: An Open-Label, Nonrandomized Clinical Trial.
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Tremonti C, Blogg J, Jamshidi N, Harjanto R, Miles N, Ismay C, Page R, Mills L, Buckley N, Perananthan V, Lintzeris N, and Haber P
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Aims: To compare a low-dosing protocol to standard practice for methadone-buprenorphine transfers., Methods: We undertook a nonrandomized open-label clinical trial across 8 sites from NSW, Australia. Participants prescribed methadone wishing to transfer to buprenorphine could either choose or be randomized to a low-dose transfer or standard care transfer as per NSW health guidelines. The low-dose protocol started at 0.2 mg BD and increased to 16 mg on day 6, with flexible dosing thereafter. The primary outcome was continuation of buprenorphine 1 week post-transfer. Binary logistic regression was used to access the primary outcome with demographic differences between the groups included as covariates., Results: There were 117 participants who commenced the study, 101 in the low-dose arm and 16 in standard care. Mean methadone dose was 82 mg in the low-dose arm and 46 mg in standard care. The primary outcome was met by 81 participants in the low-dose arm (80%) and 13 participants in standard care (81%). There was no significant between-arm difference in the odds of the primary outcome (OR = 2.22; 95% CI: 0.45-10.91; P = 0.327). Four participants (4%) in the low-dose arm experienced precipitated withdrawal against 1 (6%) in standard care. Higher methadone dose decreased the odds of successful transfer by 20% (OR = 0.8 per 10 mg methadone; 95% CI: 0.7-0.99; P = 0.04). Withdrawal scores between the 2 arms were similar., Conclusions: We were unable to detect a difference between low dosing and standard care for methadone to buprenorphine transfers. Increasing methadone dose was a predictor of success; setting (ambulatory or inpatient) was not., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 American Society of Addiction Medicine.)
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- 2024
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106. Sociodemographic and Health Factors of the Alcohol Treatment-seeking Population in New South Wales, Australia.
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Heijstee N, Black E, Black E, Demirkol A, Mammen K, Mills L, Deacon R, Ezard N, Montebello M, Reid D, Bruno R, Shakeshaft A, Siefried KJ, Farrell M, and Lintzeris N
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- Humans, Male, Female, New South Wales epidemiology, Adult, Middle Aged, Young Adult, Adolescent, Alcohol Drinking epidemiology, Sociodemographic Factors, Aged, Alcoholism epidemiology, Alcoholism therapy, Health Status, Patient Acceptance of Health Care statistics & numerical data
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Objectives: Although factors associated with alcohol use have been researched at a population level, descriptions of the alcohol and other drug (AOD) treatment-seeking population in New South Wales (NSW), Australia, are limited. This study addresses this gap by analyzing sociodemographic and health characteristics in the NSW AOD treatment-seeking population., Methods: Self-reported Australian Treatment Outcomes Profile data on substance use, health ratings, and sociodemographic factors were acquired from public AOD services (offering services from counseling to ambulatory/inpatient withdrawal management) in 6 administrative health districts from 2016 to 2019 (n = 14,287). Gaussian and multiple logistic regressions were conducted to examine associations between these factors and alcohol consumption quantity., Results: Data were analyzed for patients seeking treatment for alcohol consumption specifically (n = 5929; median age, 44 years; 65% male). Valid alcohol consumption data were available for 5460 patients, among whom the mean volume of alcohol consumed was 311 standard drinks (3110 grams of ethanol) over the past 28 days and 15 standard drinks (150 grams of ethanol) per occasion. Higher volumes were consumed by males and those with recent experiences of violence and/or injecting drug use. Caring for children younger than 5 years and having above-median health ratings were associated with lower alcohol consumption., Conclusions: This study contributes to the characterization of the NSW public AOD treatment population and identifies associations between alcohol consumption, sociodemographic factors, and health ratings among people seeking treatment for alcohol consumption. Findings point towards multilevel assessment and comprehensive interventions for people engaging in treatment for alcohol use. Future research should address barriers to treatment., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 American Society of Addiction Medicine.)
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- 2024
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107. Interconnections between unintended pregnancy, alcohol and other drug use, and pregnancy, birth, infant, childhood and socioeconomic outcomes: a scoping review.
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McNamara KA, Murnion B, Fotheringham P, Terplan M, Lintzeris N, Oei JL, Bond DM, Nassar N, and Black KI
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- Humans, Pregnancy, Female, Pregnancy Outcome epidemiology, Alcohol Drinking epidemiology, Infant, Infant, Newborn, Child, Socioeconomic Factors, Pregnancy, Unplanned, Substance-Related Disorders epidemiology, Substance-Related Disorders psychology
- Abstract
Background: Unintended pregnancy (UIP) and substance use disorder share underlying root causes with similar impacts for women and their offspring in pregnancy, birth and beyond. Furthermore, intoxication with alcohol and other drugs (AOD) increases the risk of UIP., Objectives: To assess the available evidence on associations between UIP and health, social and economic outcomes, in women who use AOD., Search Strategy: The review utilised the Joanna Briggs Institute Methodology for Scoping Reviews and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines. The search was conducted across multiple databases, including Scopus and Medline, and limited to studies published between January 2000 to June 2023., Selection Criteria: Studies reporting on interactions between AOD use and UIP, and pregnancy, birth, infant, childhood, social or economic outcomes. All patterns and types of AOD use, except isolated use of tobacco, were included. Studies were available in English and conducted in high-income countries., Data Collection and Analysis: Selected articles were reviewed, and data collected by two independent reviewers using a standardised data extraction sheet. Findings were summarised and reported descriptively., Main Results: A total of 2536 titles and abstracts were screened, 97 full texts were reviewed, and three studies were selected for inclusion in the scoping review. There was heterogeneity in types and patterns of AOD use, differences in study design and tools to assess pregnancy intention, and each focused on disparate outcomes. No study assessed or reported on birth outcomes., Conclusion: There is a paucity of data examining the intersection between AOD use and UIP and further research is needed., Competing Interests: Competing interests: NL has received funding for unrelated research projects from Camurus AB, Indivior and the National Health and Medical Research Centre. KMN has received funding from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists; however, no funds were directed to this project. No other authors have disclosures of interest., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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108. Integration of a facilitated access pathway for contraception into alcohol and other drug treatment services: A cohort study comparing metropolitan and regional settings.
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McNamara KA, Murnion B, Lintzeris N, Chase V, Black E, Malcolm A, Harvey Dodds L, Nassar N, and Black KI
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Introduction: Women who attend alcohol and other drug (AOD) services experience higher rates of unintended pregnancy, and access less contraception, than the general population. This study aims to observe contraceptive initiation and use after contraception services were offered at metropolitan and regional AOD services., Methods: Clinical staff were provided contraception education. One hundred women aged 16-49 were recruited from two services between 2017 and 2021. Women completed a questionnaire on their obstetrics and gynaecological history, pregnancy plans and contraception use. Women were provided education on contraception options and offered referral to a contraception pathway. The primary outcome was initiation of highly reliable contraception; secondary outcomes were the types of contraception initiated, and contraception use and pregnancy at 12 months. We compared the initiation of contraception across the two study sites., Results: At baseline, 91% of women were not planning a pregnancy within 12 months, with 21% of these using highly reliable contraception. Of all women not planning a pregnancy, 28% initiated highly reliable contraception via the pathway (2% metropolitan, 51% regional, p < 0.001), with intrauterine devices being the most frequent method initiated (15%). At 12 months, 44% were using highly reliable contraception and 15% had recorded pregnancies., Discussion and Conclusions: Contraception pathways for women in AOD treatment can improve initiation of highly reliable methods of contraception, although pregnancy rates were still high and there were large differences between the study sites. Care navigation and clinical champions are some potential facilitators to contraception access, and understanding additional barriers to access may be useful., (© 2024 The Author(s). Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2024
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109. Provider costs of treating opioid dependence with extended-release buprenorphine in Australia.
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Settumba S, Shahbazi J, Byrne M, Degenhardt L, Grebely J, Larance B, Nielsen S, Lintzeris N, Ali R, Rodgers C, Blazey A, Weiss R, Dunlop A, McDonough M, Cook J, and Farrell M
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Introduction: The costs of providing medication-assisted treatment for opioid dependence can determine its scale of provision. To provide estimates of the costs of extended-release buprenorphine (BUP-XR), we performed a bottom-up costing analysis of provider operational treatment costs., Methods: Data were collected in a single-arm open label trial of BUP-XR injections conducted in specialist public drug treatment services and primary care private practices in three Australian states (the CoLAB study). The unit costs of resources used for each activity were combined with quantities used at each participating facility to arrive at the average annual cost per client., Results: One hundred participants across the six health facility sites received monthly subcutaneous BUP-XR injections administered by a health-care practitioner. The average cost of providing 1 year of treatment per participant was $6656 ($6026-$8326). Screening cost (initial assessment and medical history) was $282 while monthly follow-up appointments cost $531 per client. The main cost driver was the monthly treatment costs accounting for 79% of the average annual client cost, with medication costs comprising 95% of this cost., Discussion and Conclusion: With medication costs making up the largest proportion of treatment costs, treatment using BUP-XR has the potential to free up other health system resources, for example, staff time. The costs reported in this study can be used in an economic evaluation to estimate the net benefit or cost-effectiveness of BUP-XR especially when compared to other opioid agonist treatments., (© 2024 The Author(s). Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2024
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110. Implementation of time-limited parenteral hydromorphone in people with treatment-resistant injecting opioid use disorder: a protocol for a single-site, uncontrolled, open-label study to assess feasibility, safety and cost.
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Rodgers C, Siefried KJ, Ritter A, Belackova V, Treloar C, Jauncey M, Ezard N, Roberts D, Steele M, van den Brink W, Strang J, Oviedo-Joekes E, Lintzeris N, Dunlop AJ, and Bell J
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- Humans, Australia, Substance Abuse, Intravenous drug therapy, Opiate Substitution Treatment methods, Opiate Substitution Treatment economics, Hydromorphone administration & dosage, Hydromorphone therapeutic use, Feasibility Studies, Analgesics, Opioid administration & dosage, Analgesics, Opioid therapeutic use, Opioid-Related Disorders drug therapy
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Introduction: Supervised injectable opioid treatment (SIOT) is an evidence-based intervention targeting opioid-dependent people for whom existing treatments have been ineffective. This project will primarily assess the feasibility and the acceptability of time-limited SIOT using injectable hydromorphone delivered in an existing Australian public opioid treatment programme, with secondary outcomes of safety, cost, changes in drug use and other health outcomes. If feasible, the goal is to scale up the intervention to be more widely available in Australia., Methods and Analysis: Between 20 and 30 participants will be offered two times per day hydromorphone to inject under direct observation, in addition to their current opioid agonist treatment (OAT), for up to 2 years. At the end of 2 years of supervised hydromorphone treatment, participants will be continued on standard OAT only. Informed consent will be obtained from all participants included in the study. This is a single-site, uncontrolled, open-label study where quantitative and qualitative interview data will be collected at baseline, 12 months and lastly at 3 months following their final hydromorphone dose. The main outcome measures are feasibility, as assessed by recruitment, retention and participation in treatment, and acceptability to participants, clinic staff and other stakeholders assessed by qualitative interviews. Secondary outcome measures of safety, as assessed by adverse events, and cost will also be assessed, as well as a range of other drug and health outcomes., Ethics and Dissemination: This study received ethical approval from the St Vincent's Hospital Human Research Ethics Committee (2019/ETH00418). This will be the first study of time-limited SIOT in the Australian setting. All results will be submitted to peer-reviewed journals, scientific conferences and local practice meetings. A preliminary report on outcomes will also be presented to local health policy makers. A consumer and community forum will also be held to feedback results to a broader audience., Trial Registration Number: ACTRN12621001729819., Competing Interests: Competing interests: JS, through his university, has worked with several pharmaceutical companies to identify new or improved treatments and his employer (King’s College London) has received grants, travel costs and/or consultancy payments. None of these is related to the FOpIT study described in this paper. NL has received funding for independent research from Indivior and Camurus for work unrelated to this project. KJS and NE have received funding from the Australian Department of Health and Aged Care, and is employed by the University of New South Wales and St Vincent’s Hospital, Sydney. WvdB has worked with several pharmaceutical companies to identify new or improved treatments and received speaker fees, travel costs and/or consultancy payments. None of these is related to the FOpIT study described in this paper., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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111. Medical cannabis use in Australia seven years after legalisation: findings from the online Cannabis as Medicine Survey 2022-2023 (CAMS-22).
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Mills L, Arnold JC, Suraev A, Abelev SV, Zhou C, Arkell TR, McGregor IS, and Lintzeris N
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- Humans, Australia epidemiology, Male, Adult, Female, Middle Aged, Young Adult, Adolescent, Surveys and Questionnaires, Aged, Medical Marijuana therapeutic use
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Background: Cannabis was legalised for medical purposes in 2016. Uptake was initially slow, but since 2019 there has been a large increase in the number of Australians who have been prescribed cannabis for medical reasons. Yet a significant number of consumers continue to treat their medical conditions via illicitly-sourced cannabis. Little is known about how these two groups of medical cannabis consumers differ., Methods: The anonymous Cannabis-As-Medicine Survey 2022-2023 (CAMS-22) was available for completion online from December 2022 to April 2023 to adult Australians who had used cannabis to treat a medical condition in the previous year. Recruitment occurred through social media, consumer forums, and medical practices. Questions included demographic characteristics, patterns of cannabis use, conditions treated, and self-rated effectiveness., Results: Of the 3323 respondents included in these analyses, 2352 (73%) mainly used prescribed medical cannabis, 871 (27%) mainly used illicit. Prescribed users were significantly more likely than illicit users to have had their health condition diagnosed (OR = 1.7, 95% CI 1.3, 2.2), to consume their cannabis via oral (OR = 1.9; CI 1.5, 2.4) or vaporised (OR = 5.2; CI 4.0, 6.8) routes, and to be sure of the composition of their medical cannabis (OR = 25.0; CI 16.7, 50.0). Prescribed users were significantly less likely to have used cannabis non-medically before medical use (OR = 0.6, CI 0.5, 0.7), consume cannabis via smoked routes (OR = 0.2, CI 0.1, 0.2), and to report any side effects (OR = 0.1; CI 0.1, 0.2). The most common conditions among both prescribed and illicit users were pain (37%), mental health (36%), and sleep (15%) conditions. Prescribed users were significantly more likely to use cannabis to mainly treat a pain (OR = 1.3; CI 1.1, 1.5) or sleep condition (OR = 1.4; CI 1.1, 1.7) and less likely to treat a mental health condition (OR = 0.8; CI 0.7, 0.9). There were no between-group differences in effectiveness with 97% saying medical cannabis had improved their symptoms., Conclusions: From a harm-reduction perspective there is much to recommend prescribed medical cannabis; it has fewer side-effects than illicit, is used more safely (oral or vaporised versus smoked routes), gives consumers greater certainty regarding the composition and quality of their medicine, and does not risk exposure to the criminal justice system. Of concern, however, is the apparent willingness of prescribers to prescribe for indications for which there is limited evidence of efficacy, such as mental health and sleep conditions., (© 2024. Crown.)
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- 2024
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112. The dynamics of more-than-human care in depot buprenorphine treatment: A new materialist analysis of Australian patients' experiences.
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Barnett A, Pienaar K, Lubman DI, Arunogiri S, Phan V, Hayes V, Lintzeris N, and Savic M
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- Humans, Male, Female, Adult, Middle Aged, Australia, Qualitative Research, Narcotic Antagonists administration & dosage, Interviews as Topic, Methadone administration & dosage, Buprenorphine administration & dosage, Opioid-Related Disorders drug therapy, Opiate Substitution Treatment, Delayed-Action Preparations
- Abstract
Background: Long-acting injectable depot buprenorphine has become an important treatment option for the management of opioid dependence. However, little is known about patients' experiences of depot buprenorphine and its embodied effects. This qualitative study aims to explore patients' experiences of depot buprenorphine treatment, including how it feels within the body, experiences of dosing cycles across time, and how this form of treatment relies on wider ecologies of care beyond the clinical encounter., Methods: Participants were recruited from sites in Sydney, regional New South Wales, and Melbourne, Victoria, Australia. Thirty participants (16 men, 14 women) participated in semi-structured interviews. Participants had histories of both heroin and prescription opioid consumption, and opioid agonist therapy including daily dosing of buprenorphine and methadone., Results: Our analysis illuminates: (1) how patients' expectations and concerns about treatment are linked to past embodied experiences of withdrawal and uncertainty about the effectiveness of depot buprenorphine; (2) the diverse meanings patients attribute to the depot buprenorphine substrate 'under the skin'; and, (3) how depot buprenorphine is embedded within wider ecologies of care, such as counselling and social supports., Conclusion: Our analysis destabilises commonplace assumptions about a linear, causal relationship between the pharmacological action of depot buprenorphine and experiences of treatment. Instead, it highlights patients' variable experiences of depot buprenorphine, tracing the everyday practices, embodied feelings, expectations and wider networks of care that shape patient experiences. We conclude with some reflections on the implications of our analysis for alcohol and other drug treatment, specifically how they might inform the design of client education materials and care., Competing Interests: Declaration of competing interest ROLE OF FUNDING SOURCE This research was supported by funding from Camurus AB. SA is supported by a National Health and Medical Research Council Investigator Grant (GNT2008193). SA has received honoraria for advisory board attendance from Camurus and Indivior, and speaker honoraria from Camurus, Indivior, Gilead, Janssen and Servier unrelated to this work. VH has received funding from Camurus AB and ViiV Healthcare to provide training. NL has received honoraria for attendance on Advisory Boards for Indivior, Mundipharma and Chiesi Pharmaceuticals, and has received research funding from Camurus AB for unrelated research. DL has previously received speaking honoraria from AstraZeneca, Camurus, Indivior, Janssen, Servier, Shire and Lundbeck and has provided consultancy advice to Lundbeck and Indivior. DL is supported by a NHMRC Investigator grant (1196892). Other than support received from Camurus AB for this project, AB, MS, KP and VP have no funding disclosures to declare., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2024
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113. 96-week retention in treatment with extended-release subcutaneous buprenorphine depot injections among people with opioid dependence: Extended follow-up after a single-arm trial.
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Farrell M, Shahbazi J, Chambers M, Byrne M, Gholami J, Zahra E, Grebely J, Lintzeris N, Larance B, Ali R, Nielsen S, Dunlop A, Dore GJ, McDonough M, Montebello M, Weiss R, Rodgers C, Cook J, and Degenhardt L
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- Humans, Male, Female, Adult, Prospective Studies, Injections, Subcutaneous, Follow-Up Studies, Middle Aged, Australia, Treatment Outcome, Narcotic Antagonists administration & dosage, Quality of Life, Analgesics, Opioid administration & dosage, Opioid-Related Disorders drug therapy, Buprenorphine administration & dosage, Delayed-Action Preparations, Opiate Substitution Treatment methods
- Abstract
Background: The most recent formulation of buprenorphine treatment is extended-release depot injections (BUP-XR) that are administered subcutaneously by health care professionals. This study aimed to observe treatment outcomes of BUP-XR delivered in standard practice during a 96-week follow-up period in a community setting., Methods: This study is an extension of the CoLAB study, a prospective single-arm, multicentre, open label trial (N=100, 7 sites in Australia) among people with opioid dependence who received monthly injections of BUP-XR to evaluate the retention in treatment. Participants were followed for 96 weeks, comprising 48 weeks of the CoLAB study followed by a 48-week extension., Results: Of 100 participants at baseline, 47 were retained on BUP-XR at 96 weeks. The median time retained on monthly depot was 90 weeks. Heroin use (adjusted OR=0.19, P=0.012) in the month prior to baseline was associated with lower odds of retention on BUP-XR. Older age at first opioid use (adjusted OR= 1.08, P=0.009) and longer duration in OAT at baseline (adjusted OR= 1.12, P=0.001) were associated with increased retention. Prevalence of past four-weeks opioid use was estimated at 4% at 96 weeks of treatment (prevalence 0.04, 95%CI: 0.00-0.11) compared to 15% at baseline. Quality of life and medication treatment satisfaction improved over time for those retained in treatment., Conclusion: This is one of the few studies to describe long term (96 week) retention in treatment with BUP-XR in a community setting. It displayed retention rates with 47% of participants completing 96 weeks of treatment with BUP-XR. Patient reported outcomes suggest improvements in client wellbeing., Funding: Indivior., Competing Interests: Declaration of competing interest This study was supported by an Externally Sponsored Collaborative Research grant from Indivior PLC (MF, BL, LD, NL, AD, RA, SN, GD, J Grebely). In the past three years, MF and LD have received funding from Indivior for studies of new opioid medications in Australia. J Grebely reports grants and personal fees from Abbvie, bioLytical, Camurus, Cepheid, Hologic, Indivior, and Gilead Sciences. NL has received reimbursement for participation in Advisory Boards for Mundipharma, Indivior and Chiesi Pharmaceuticals; he received funding from Camurus for a company-sponsored trial of BUP-XR. RA has received untied educational grants from Reckitt Benckiser and an untied educational grant from Mundipharma. AJD reports grants from Braeburn/Camurus AB, to conduct clinical studies with buprenorphine products and travel support to Hunter New England Local Health District, which employs AJD. GJD has received research grant funding from Gilead and Abbvie. MM has served as an honorary on advisory boards for Pfizer and AbbVie. MC, JS, MB, JG, and EZ have no conflicts to declare. SN has received untied research funding from Seqirus to conduct research on prescription opioid related harms., (Crown Copyright © 2024. Published by Elsevier B.V. All rights reserved.)
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- 2024
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114. An International, Multidisciplinary Consensus Set of Patient-Centered Outcome Measures for Substance-Related and Addictive Disorders.
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Black N, Chung S, Tisdale C, Fialho LS, Aramrattana A, Assanangkornchai S, Blaszczynski A, Bowden-Jones H, van den Brink W, Brown A, Brown QL, Cottler LB, Elsasser M, Ferri M, Florence M, Gueorguieva R, Hampton R, Hudson S, Kelly PJ, Lintzeris N, Murphy L, Nadkarni A, Neale J, Rosen D, Rumpf HJ, Rush B, Segal G, Shorter GW, Torrens M, Wait C, Young K, and Farrell M
- Abstract
Background: In 1990, the United States' Institute of Medicine promoted the principles of outcomes monitoring in the alcohol and other drugs treatment field to improve the evidence synthesis and quality of research. While various national outcome measures have been developed and employed, no global consensus on standard measurement has been agreed for addiction. It is thus timely to build an international consensus. Convened by the International Consortium for Health Outcomes Measurement (ICHOM), an international, multi-disciplinary working group reviewed the existing literature and reached consensus for a globally applicable minimum set of outcome measures for people who seek treatment for addiction. Methods: To this end, 26 addiction experts from 11 countries and 5 continents, including people with lived experience ( n = 5; 19%), convened over 16 months (December 2018-March 2020) to develop recommendations for a minimum set of outcome measures. A structured, consensus-building, modified Delphi process was employed. Evidence-based proposals for the minimum set of measures were generated and discussed across eight videoconferences and in a subsequent structured online consultation. The resulting set was reviewed by 123 professionals and 34 people with lived experience internationally. Results: The final consensus-based recommendation includes alcohol, substance, and tobacco use disorders, as well as gambling and gaming disorders in people aged 12 years and older. Recommended outcome domains are frequency and quantity of addictive disorders, symptom burden, health-related quality of life, global functioning, psychosocial functioning, and overall physical and mental health and wellbeing. Standard case-mix (moderator) variables and measurement time points are also recommended. Conclusions: Use of consistent and meaningful outcome measurement facilitates carer-patient relations, shared decision-making, service improvement, benchmarking, and evidence synthesis for the evaluation of addiction treatment services and the dissemination of best practices. The consensus set of recommended outcomes is freely available for adoption in healthcare settings globally.
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- 2024
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115. Participant experiences in a pilot study for methamphetamine withdrawal treatment: Implications for retention.
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Acheson LS, Clay S, McKetin R, Lintzeris N, Dunlop A, Brett J, Christmass M, Rodgers C, Shoptaw S, Farrell M, Ezard N, and Siefried KJ
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- Humans, Male, Pilot Projects, Female, Adult, Middle Aged, Communication, Trust, Interviews as Topic, Clinical Trials as Topic, Methamphetamine administration & dosage, Methamphetamine adverse effects, Substance Withdrawal Syndrome drug therapy, Amphetamine-Related Disorders
- Abstract
Introduction: There is little knowledge of the perspectives of people who use methamphetamine and have participated in clinical trials, and none for interventions not intended to address abstinence. A better understanding of these experiences could lead to more patient centred clinical trial design. This study seeks to understand the experiences of people who completed a clinical trial of lisdexamfetamine for the treatment of acute methamphetamine withdrawal., Methods: Thematic analysis of open-ended, semi-structured interviews with eight people who participated in an inpatient clinical trial of lisdexamfetamine for acute methamphetamine withdrawal. Interviews were conducted between days 3 and 6 of admission to an inner-city Sydney hospital., Results: Participants described how research procedures, the research setting, and the investigational product affected their experiences while enrolled in a clinical trial. Of particular importance to participants were transparent and low burden trial procedures, a welcoming trial environment, trusting relationships and effective communication, which were linked with the participants' subsequent decision to remain enrolled in the trial., Discussion: The experiences of participants in this clinical trial can be distilled into four meta-themes: agency, caring-trust, safety, and communication. Participants spontaneously linked these experiences with a capacity to remain enrolled in the study. By considering the experiences of trial participants in clinical trial design, researchers can improve the experiences of future trial participants and facilitate their choice to remain enrolled in clinical trials., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: LSA is supported by an NDARC PhD Scholarship. MF has received unrestricted funding for research purposes from Indivior and Sequiiris. SS has received clinical research supplies from Alkermes. NE and KJS are employed by NCCRED. No other investigators have any conflicts of interest to declare., (Copyright © 2024. Published by Elsevier B.V.)
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- 2024
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116. The uptake of long-acting depot buprenorphine for treating opioid dependence in Australia, 2019-2022: longitudinal sales data analysis.
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Lintzeris N, Hayes V, and Dunlop AJ
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- Humans, Analgesics, Opioid therapeutic use, Australia epidemiology, Narcotic Antagonists therapeutic use, Opiate Substitution Treatment, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy
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- 2024
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117. Neuroimaging studies of cannabidiol and potential neurobiological mechanisms relevant for alcohol use disorders: a systematic review.
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Hurzeler T, Watt J, Logge W, Towers E, Suraev A, Lintzeris N, Haber P, and Morley KC
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The underlying neurobiological mechanisms of cannabidiol's (CBD) management of alcohol use disorder (AUD) remains elusive.Aim We conducted a systematic review of neuroimaging literature investigating the effects of CBD on the brain in healthy participants. We then theorise the potential neurobiological mechanisms by which CBD may ameliorate various symptoms of AUD.Methods This review was conducted according to the PRISMA guidelines. Terms relating to CBD and neuroimaging were used to search original clinical research published in peer-reviewed journals.Results Of 767 studies identified by our search strategy, 16 studies satisfied our eligibility criteria. The results suggest that CBD modulates γ-Aminobutyric acid and glutamate signaling in the basal ganglia and dorso-medial prefrontal cortex. Furthermore, CBD regulates activity in regions associated with mesocorticolimbic reward pathways; salience, limbic and fronto-striatal networks which are implicated in reward anticipation; emotion regulation; salience processing; and executive functioning.Conclusion CBD appears to modulate neurotransmitter systems and functional connections in brain regions implicated in AUD, suggesting CBD may be used to manage AUD symptomatology., (© 2024. The Author(s).)
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- 2024
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118. A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol.
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Bhardwaj AK, Mills L, Doyle M, Sahid A, Montebello M, Monds L, Arunogiri S, Haber P, Lorenzetti V, Lubman DI, Malouf P, Harrod ME, Dunlop A, Freeman T, and Lintzeris N
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- Adult, Humans, Quality of Life, Australia, Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic, Cannabidiol therapeutic use, Anti-Anxiety Agents, Hallucinogens, Substance-Related Disorders, Cannabis, Antipsychotic Agents, Marijuana Abuse
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Background: Cannabis use disorder (CUD) is increasingly common and contributes to a range of health and social problems. Cannabidiol (CBD) is a non-intoxicating cannabinoid recognised for its anticonvulsant, anxiolytic and antipsychotic effects with no habit-forming qualities. Results from a Phase IIa randomised clinical trial suggest that treatment with CBD for four weeks reduced non-prescribed cannabis use in people with CUD. This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD., Methods/design: A phase III multi-site, randomised, double-blinded, placebo controlled parallel design of a 12-week course of CBD to placebo, with follow-up at 24 weeks after enrolment. Two hundred and fifty adults with moderate-to-severe CUD (target 20% Aboriginal), with no significant medical, psychiatric or other substance use disorders from seven drug and alcohol clinics across NSW and VIC, Australia will be enrolled. Participants will be administered a daily dose of either 4 mL (100 mg/mL) of CBD or a placebo dispensed every 3-weeks. All participants will receive four-sessions of Cognitive Behavioural Therapy (CBT) based counselling. Primary endpoints are self-reported cannabis use days and analysis of cannabis metabolites in urine. Secondary endpoints include severity of CUD, withdrawal severity, cravings, quantity of use, motivation to stop and abstinence, medication safety, quality of life, physical/mental health, cognitive functioning, and patient treatment satisfaction. Qualitative research interviews will be conducted with Aboriginal participants to explore their perspectives on treatment., Discussion: Current psychosocial and behavioural treatments for CUD indicate that over 80% of patients relapse within 1-6 months of treatment. Pharmacological treatments are highly effective with other substance use disorders but there are no approved pharmacological treatments for CUD. CBD is a promising candidate for CUD treatment due to its potential efficacy for this indication and excellent safety profile. The anxiolytic, antipsychotic and neuroprotective effects of CBD may have added benefits by reducing many of the mental health and cognitive impairments reported in people with regular cannabis use., Trial Registration: Australian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023)., (© 2024. Crown.)
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- 2024
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119. Differences in prescribed medicinal cannabis use by cannabinoid product composition: Findings from the cannabis as medicine survey 2020 (CAMS-20) Australia-wide study.
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Trevitt BT, Bailey S, Mills L, Arkell TR, Suraev A, McGregor IS, and Lintzeris N
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- Humans, Male, Female, Cross-Sectional Studies, Australia, Pain chemically induced, Cannabinoid Receptor Agonists, Dronabinol adverse effects, Cannabinoids adverse effects, Cannabinoids analysis, Cannabis, Medical Marijuana adverse effects, Hallucinogens, Cannabidiol
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Introduction: Prescribed medicinal cannabis (MC) is an increasingly common prescription in Australia for treating pain, anxiety, and sleep disorders. Prescribed MC products generally contain tetrahydrocannabinol (THC) and/or cannabidiol (CBD) in a variety of dose levels and forms. It is unclear whether THC and CBD products are used by patients with different characteristics and for different conditions., Objectives: To examine consumer experiences of using THC- and CBD-containing prescribed MC products to better understand how they are being used within the Australian context., Methods: We utilised data collected from an online anonymous cross-sectional survey of individuals (CAMS-20 survey), consisting of Australian residents using cannabis for therapeutic reasons. We focused on a subgroup of participants (N = 546) receiving prescribed MC products. We utilised linear, logistic, and multinomial regression modelling to analyse responses to survey questions based on the cannabinoid profile of the prescribed product., Results: Participants prescribed THC-dominant MC products were statistically more likely to be younger, male, and to prefer inhaled routes of administration than participants using CBD-dominant products who were older, female, and preferred oral routes of administration. Pain and mental health were the most common reasons for all types of prescribed MC, but were more likely to be treated with THC than CBD despite the significantly higher risk of mild to severe drowsiness, dry mouth and eye irritation. Consumer reported effectiveness of prescribed MC was very positive, particularly for THC-containing products. Consumers on opioids and antipsychotics were statistically more likely to be prescribed THC-containing products than products containing CBD only, despite the greater risk of impairment., Conclusions: This Australia-wide study found clear differences in consumer-reported experiences of prescribed THC- and CBD-containing products. Current prescriptions of these products do not always align with relevant clinical guidance. Educating prescribers around cannabinoid products is essential to ensure optimal prescribing practices and to prevent avoidable drug side effects and interactions., Competing Interests: Professor Nicholas Lintzeris reports receiving grants from the Australian National Health and Medical Research Council (NHMRC) during the conduct of the study and research grants from Camurus and Indivior – all for unrelated work. Professor Ian McGregor reports receiving grants from Lambert Initiative for Cannabinoid Therapeutics and from NHMRC during the study, but for unrelated projects. Professor Ian McGregor also has patents to WO2018107216A1, WO2017004674A1 and WO2011038451A1 issued and licensed, as well as patents to AU2020050941, AU2019903299, AU2017904438, AU2017904072 and AU2018901971 pending, and a patent WO2019227167 and WO2019071302 issued. Dr Thomas Arkell reports receiving grants from Swinburne University of Technology and the Victorian Department of Health for unrelated projects. No other authors report conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Trevitt et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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120. The impact of changes in opioid dependency treatment upon COVID-19 transmission in Sydney, Australia: a retrospective longitudinal observational study.
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Trevitt BT, Hayes V, Deacon R, Mills L, Demirkol A, and Lintzeris N
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- Adult, Humans, Australia epidemiology, Analgesics, Opioid therapeutic use, Retrospective Studies, Case-Control Studies, COVID-19 epidemiology, Opioid-Related Disorders drug therapy, Opioid-Related Disorders epidemiology, Buprenorphine therapeutic use
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Background: In April 2020, in response to the COVID-19 public health emergency, South Eastern Sydney Local Health District (SESLHD) Drug and Alcohol services modified their delivery of opioid dependency treatment (ODT) to reduce spread of COVID-19 and maintain continuity of care by increasing use of takeaway doses (TADs), transferring clients to local community pharmacies for dosing and encouraging the use of long-acting depot buprenorphine (LADB) which enabled once a month dosing., Methods: This study was a retrospective longitudinal case-control study conducted from August 1st, to November 30th, 2021. Eligible clients were those admitted for treatment with SESLHD ODT Services prior to August 1st,2021 and who remained in treatment beyond November 30th, 2021. COVID-19 diagnoses were determined by a COVID-19 PCR and extracted from the electronic Medical Records (eMR) Discern Reporting Portal. Demographic, clinical and dosing related data were collected from eMR and the Australian Immunisation Register (AIR)., Results: Clients attending SESLHD ODT services had significantly greater odds of acquiring COVID-19 than the NSW adult population at large (OR: 13.63, 95%CI: 9.64,18.88). Additionally, amongst SESLHD ODT clients, being of Aboriginal and Torres Strait Islander origin was associated with greater odds of acquiring COVID-19 (OR = 2.18, CI: 1.05,4.53); whilst being employed (OR = 0.06, CI:0.01,0.46), receiving doses at pharmacy (OR = 0.43, CI: 0.21,0.89), and being vaccinated (OR = 0.12, CI: 0.06,0.26) were associated with lower odds. Every additional day of attendance required for dosing was associated with a 5% increase in odds of acquiring COVID-19 (OR = 1.05, CI: 1.02,1.08)., Conclusions: Clients attending SESLHD ODT services are significantly more likely to acquire COVID-19 than the NSW population at large. Promoting vaccination uptake, transferring clients to pharmacy, and reducing the frequency of dosing (by use of takeaway doses or long-acting depot buprenorphine) are all potential methods to reduce this risk., (© 2024. The Author(s).)
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- 2024
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121. Understanding the research capacity of alcohol and other drugs services in New South Wales, Australia.
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Stirling R, Hudson S, Ross J, Deans E, Tibbetts J, Day C, Deacon R, Dunlop A, and Lintzeris N
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- Humans, New South Wales, Australia, Public Health, Carcinoma, Renal Cell, Kidney Neoplasms
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Introduction: Enhancing health system research capacity can support improved quality care. This study assessed the research capacity of public local health district (LHD) and non-government organisation (NGO) alcohol and other drug (AOD) services, at the organisational, team and individual level. Research barriers and motivators were also examined., Methods: Staff from LHD and NGO AOD treatment services in New South Wales completed an online survey using the Research Capacity and Culture (RCC) tool. Overall median research capacity scores are presented for the RCC subscales (organisational, team and individual). Comparisons were conducted by service type (LHD/NGO), geographical location (metropolitan/rural) and affiliation with a research network (yes/no). Qualitative questions explored barriers and motivators to research at individual and team levels., Results: Of 242 participants, 55% were LHD-based and 45% NGO-based. Overall RCC scores indicated moderate research capacity at all levels. Organisational capacity (Med = 6.50, interquartile range [IQR] = 3.50) scored significantly higher than the team (Med = 5.00, IQR = 6.00) and individual level (Med = 5.00, IQR = 4.25). No differences in RCC scores existed between NGOs and LHDs. Metropolitan AOD services scored higher research capacity at the organisational level (Med = 7.00, IQR = 3.00) than rural services (Med = 5.00, IQR = 5.00). LHDs affiliated with a research network scored significantly higher at the organisational, team and individual level than non-affiliated LHD services. Key research barriers were inadequate time and funding. Motivators included skill development and problem-identification requiring change., Discussions and Conclusions: AOD services in New South Wales have moderate research capacity. Identified barriers and motivators can be used to target responses that enhance capacity and improve treatment outcomes., (© 2023 Australasian Professional Society on Alcohol and other Drugs.)
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- 2024
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122. Measuring Objective and Subjective Sleep during Lisdexamfetamine Treatment of Acute Methamphetamine Withdrawal: A Feasibility Study.
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Acheson LS, Gordon C, McKetin R, Brett J, Christmass M, Rodgers C, Lintzeris N, Dunlop A, Farrell M, Shoptaw S, Ezard N, and Siefried KJ
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- Humans, Male, Adult, Female, Feasibility Studies, Sleep, Polysomnography, Actigraphy, Lisdexamfetamine Dimesylate adverse effects, Substance Withdrawal Syndrome diagnosis, Substance Withdrawal Syndrome drug therapy
- Abstract
Introduction: Sleep disturbance is common during methamphetamine (MA) use and withdrawal; however, the feasibility of combined subjective-objective measurement of sleep-wake has not been shown in this population. Actigraphy is a well-established, non-invasive measure of sleep-wake cycles with good concordance with polysomnography. This study aimed to investigate the feasibility and utility of using actigraphy and sleep diaries to investigate sleep during MA withdrawal., Methods: We conducted a feasibility and utility study of actigraphy and sleep diaries during a clinical trial of lisdexamfetamine for MA withdrawal. Participants were inpatients for 7 days, wore an actigraph (Philips Actiwatch 2) and completed a modified Consensus Sleep Diary each morning. Participants were interviewed between days 3-5., Results: Ten participants (mean age 37 years, 90% male) were enrolled. No participant removed the device prematurely. Participants interviewed (n = 8) reported that the actigraph was not difficult or distracting to wear or completion of daily sleep diary onerous. Actigraphic average daily sleep duration over 7 days was 568 min, sleep onset latency 22.4 min, wake after sleep onset (WASO) 75.2 min, and sleep efficiency 83.6%. Sleep diaries underreported daily sleep compared with actigraphy (sleep duration was 56 min (p = 0.008) and WASO 47 min (p < 0.001) less). Overall sleep quality was 4.4 on a nine-point Likert scale within the diary., Conclusions: Continuous actigraphy is feasible to measure sleep-wake in people withdrawing from MA, with low participant burden. We found important differences in self-reported and actigraphic sleep, which need to be explored in more detail., (© 2024 The Author(s). Published by S. Karger AG, Basel.)
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- 2024
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123. Identifying thresholds for clinically meaningful change among clients of drug and alcohol services using the Australian Treatment Outcomes Profile.
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Deacon RM, Mills L, Bruno R, Mammen K, Dunlop A, Childs S, Shakeshaft A, Holmes J, and Lintzeris N
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- Humans, Australia, Reproducibility of Results, Treatment Outcome, Quality of Life, Substance-Related Disorders therapy, Substance-Related Disorders psychology
- Abstract
Aims: The Austraian Treatment Outcomes Profile (ATOP) is a brief clinical outcomes tool used widely in the Australian alcohol and other drugs treatment sector to monitor clients' substance use, health, wellbeing and clinical risk factors. It has demonstrated reliability and validity, and has recommended clinical cut-offs for assessing single-occasion client-rated health scores. This study determined clinically meaningful change thresholds for ATOP substance use and health and wellbeing variables for use by clinicians in monitoring client progress, and for quality improvement and service evaluation., Design, Setting and Participants: A framework for assessing clinically meaningful changes scores was developed by (1) calculating statistically reliable change thresholds using data-driven techniques with a reference sample of clinical ATOP data and (2) conducting a multi-disciplinary subject matter expert group to review the utility and validity of data-derived clinically meaningful change. The study was conducted within Outpatient Alcohol and Other Drug treatment services in New South Wales, Australia. The reference sample comprised 6100 ATOPs from clients at entry to public outpatient Alcohol and Other Drug treatment services; the subject matter expert group comprised 29 key stakeholders from the specialist alcohol and other drug treatment sector., Measurements and Findings: We used the Reliable Change Index method to calculate clinically meaningful change thresholds for ATOP variables. For substance use variables, a change of 30% in days of use in the last 28 (minimum 4 days) was the threshold for clinically meaningful change for substance use; for health and wellbeing variables, a change of 2 or more points in psychological health, physical health or quality of life scores (measured on 0-10 scales) was the minimum clinically meaningful change., Conclusions: Clinically meaningful change thresholds have been proposed for Australian Treatment Outcomes Profile substance use and health and wellbeing items, based on statistical reliability and subject matter expert assessment. These will be used in the development of an outcomes metric for assessing change and assigning meaning in aggregated data for evaluation of services., (© 2023 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)
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- 2023
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124. A systematic review on the effect of routine outcome monitoring and feedback on client outcomes in alcohol and other drug treatment.
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Cordony I, Mills L, Mammen K, and Lintzeris N
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- Humans, Feedback, Treatment Outcome, Outcome Assessment, Health Care, Mental Health, Substance-Related Disorders therapy
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Issues: Routine outcome monitoring (ROM) involves regularly measuring clients' outcomes during treatment, which can then be fed back to clinicians and/or clients. In the mental health field, ROM and feedback have been shown to improve client outcomes; however, no systematic reviews have examined whether improvement is also seen in alcohol and other drug (AOD) treatment outcomes. This review examines whether feedback to clients and/or clinicians of ROM data in AOD treatment improves future client outcomes., Approach: This systematic review of papers identified in Medline, PsycInfo and Scopus examines the effect on client outcomes of feeding back ROM data to clinicians and/or clients in AOD treatment settings. Key client outcomes included substance use, treatment attendance and wellbeing measures., Key Findings: Ten studies were included-five randomised controlled trials and five pre-post within-subjects designs. Six studies were deemed good- or fair-quality. Of these six, three provided feedback to clinicians only, one to clients only, and two to both clients and clinicians. Only one of the six found feedback was associated with significant reductions in substance use and only among off-track clients. Four of the six found feedback improved other outcomes, including treatment retention, global functioning, therapeutic alliance and mood symptoms., Conclusions: There may be some positive effects for clients of providing feedback to clients and/or clinicians; however, the small number of randomised trials and the heterogeneity of methods, outcome measures and findings, mean that firm conclusions cannot be drawn about the efficacy of feedback until larger randomised studies are conducted., (© 2023 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2023
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125. Driving-related behaviors, attitudes, and perceptions among Australian medical cannabis users: results from the CAMS 20 survey.
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Arkell TR, Abelev SV, Mills L, Suraev A, Arnold JC, Lintzeris N, and McGregor IS
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Road safety is an important concern amidst expanding worldwide access to legal cannabis. The present study reports on the driving-related subsection of the Cannabis as Medicine Survey 2020 (CAMS-20) which surveyed driving-related behaviors, attitudes, and perceptions among Australian medical cannabis (MC) users. Of the 1063 respondents who reported driving a motor vehicle in the past 12 months, 28% (297/1063) reported driving under the influence of cannabis (DUIC). Overall, 49-56% of respondents said they typically drive within 6 h of MC use, depending on the route of administration (oral or inhaled). Non-medical cannabis (NMC) was perceived to be more impairing for driving than MC. Binary logistic regression revealed associations between likelihood of DUIC and (1) inhaled routes of cannabis administration, (2) THC-dominant products, (3) illicit rather than prescribed use, (4) believing NMC does not impair driving, and (5) not being deterred by roadside drug testing. Overall, these findings suggest there is a relatively low perception of driving-related risk among MC users. Targeted education programs may be needed to highlight the potential risks associated with DUIC, and further research is needed to determine whether driving performance is differentially affected by MC and NMC., (© 2023. Board of Governors of the Colorado State University System, acting by and through Colorado State University-Pueblo.)
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- 2023
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126. Substance use, socio-demographic characteristics, and self-rated health of people seeking alcohol and other drug treatment in New South Wales: baseline findings from a cohort study.
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Black E, Bruno R, Mammen K, Mills L, Siefried KJ, Deacon RM, Shakeshaft A, Dunlop AJ, Ezard N, Montebello M, Childs S, Reid D, Holmes J, and Lintzeris N
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- Humans, Male, Female, New South Wales epidemiology, Cohort Studies, Analgesics, Opioid therapeutic use, Quality of Life, Australia epidemiology, Amphetamine, Ethanol, Substance-Related Disorders epidemiology, Substance-Related Disorders therapy, Central Nervous System Stimulants, Cannabis, Cocaine
- Abstract
Objective: To investigate the demographic characteristics, substance use, and self-rated health of people entering treatment in New South Wales public health services for alcohol, amphetamine-type stimulants, cannabis, cocaine, or opioids use, by principal drug of concern., Design: Baseline findings of a cohort study; analysis of data in patient electronic medical records and NSW minimum data set for drug and alcohol treatment services., Setting, Participants: People completing initial Australian Treatment Outcomes Profile (ATOP) assessments on entry to publicly funded alcohol and other drug treatment services in six NSW local health districts/networks, 1 July 2016 - 30 June 2019., Main Outcome Measures: Socio-demographic characteristics, and substance use and self-rated health (psychological, physical, quality of life) during preceding 28 days, by principal drug of concern., Results: Of 14 087 people included in our analysis, the principal drug of concern was alcohol for 6051 people (43%), opioids for 3158 (22%), amphetamine-type stimulants for 2534 (18%), cannabis for 2098 (15%), and cocaine for 246 (2%). Most people commencing treatment were male (9373, 66.5%), aged 20-39 years (7846, 50.4%), and were born in Australia (10 934, 86.7%). Polysubstance use was frequently reported, particularly by people for whom opioids or amphetamine-type stimulants were the principal drugs of concern. Large proportions used tobacco daily (53-82%, by principal drug of concern group) and reported poor psychological health (47-59%), poor physical health (32-44%), or poor quality of life (43-52%)., Conclusions: The prevalence of social disadvantage and poor health is high among people seeking assistance with alcohol, amphetamine-type stimulants, cannabis, cocaine, or opioids use problems. Given the differences in these characteristics by principal drug of concern, health services should collect comprehensive patient information during assessment to facilitate more holistic, tailored, and person-centred care., (© 2023 The Authors. Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.)
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- 2023
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127. The DACRIN data project: A process for harmonising data collection for clinical research in alcohol and other drugs services in New South Wales.
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Monds LA, Topp L, Pados J, Holmes J, and Lintzeris N
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- Humans, New South Wales, Australia, Data Collection, Substance-Related Disorders diagnosis, Substance-Related Disorders therapy
- Abstract
Introduction: Standardised data collection processes allow for harmonisation and comparison of data across different studies and services. This project aimed to develop a 'core dataset' to serve as the default collection when designing future studies and evaluations, building upon data routinely collected in clinical alcohol and other drugs (AOD) settings in NSW, Australia., Methods: A working group was established, comprising clinicians, researchers, data managers and consumers from public sector and non-government organisation AOD services in the NSW Drug and Alcohol Clinical Research and Improvement Network. A series of Delphi meetings occurred to reach consensus on the data items to be included in the core dataset for three domains: demographics, treatment activity and substance use variables., Results: There were 20-40 attendees at each meeting. An initial consensus criterion of having received >70% of the vote was established. Given the difficulty in reaching consensus for most items, subsequently, this was changed to eliminate items that received <5 votes, after which the item receiving the most votes would be selected., Discussions and Conclusions: This important process received considerable interest and buy-in across the NSW AOD sector. Ample opportunity for discussion and voting was provided for the three domains of interest, allowing participants to contribute their expertise and experience to inform decisions. As such, we believe the core dataset includes the best options currently available to collect data for these domains in the NSW AOD context, and potentially more broadly. This foundational study may inform other attempts to harmonise data across AOD services., (© 2023 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2023
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128. Health and social characteristics of clients reporting amphetamine type substance use at entry to public alcohol and other drug services in New South Wales, Australia, 2016-2019.
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Black E, Mammen K, Deacon RM, Ezard N, Mills L, Dunlop AJ, Montebello M, Reid D, Childs S, Bruno R, Shakeshaft A, Siefried KJ, Farrell M, Holmes J, and Lintzeris N
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- Humans, Australia epidemiology, New South Wales epidemiology, Quality of Life, Retrospective Studies, Ethanol, Sociological Factors, Amphetamine, Opioid-Related Disorders
- Abstract
Introduction: Amphetamine type substances (ATS) are commonly used by Australian alcohol and other drug service entrants. We describe demographic characteristics, patterns of ATS and other substance use, health and social conditions among clients entering New South Wales (NSW) public alcohol and other drug services., Methods: Retrospective cohort of 13,864 records across six health districts (2016-2019) for clients seeking substance use treatment. These districts service approximately 44% of the NSW population aged 15 years and over. Multivariate analysis was conducted on a subsample for whom full data were available (N = 9981). Data included NSW Minimum Data Set for drug and alcohol treatment services and Australian Treatment Outcomes Profile items., Results: Over the preceding 4 weeks, 77% (n = 10,610) of clients (N = 13,864) reported no recent ATS use, 15% (n = 2109) reported 'low frequency' (1-12 days) and 8% (n = 1145) 'high frequency' (13-28 days) use. ATS use was most common among people attending for ATS or opioids as primary drug of concern. A multinomial regression (N = 9981) identified that clients reporting recent arrest (aOR 1.74, 95% CI 1.36, 2.24), higher cannabis use frequency (aOR 1.01, 95% CI 1.00, 1.02), lower opioid use frequency (aOR 0.98, 95% CI 0.97, 0.99) and poorer quality of life (aOR 0.91, 95% CI 0.86, 0.97) were more likely to report 'high frequency' rather than 'low frequency' ATS use., Discussion and Conclusions: People who use ATS experience health and social issues that may require targeted responses. These should be integrated across all services, not only for clients with ATS as principal drug of concern., (© 2022 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2023
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129. Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial.
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Acheson LS, Ezard N, Lintzeris N, Dunlop A, Brett J, Rodgers C, Gill A, Christmass M, McKetin R, Farrell M, Shoptaw S, and Siefried KJ
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- Adult, Humans, Male, Lisdexamfetamine Dimesylate adverse effects, Pilot Projects, Treatment Outcome, Alcoholism drug therapy, Amphetamine-Related Disorders drug therapy, Central Nervous System Stimulants adverse effects, Methamphetamine adverse effects, Substance Withdrawal Syndrome drug therapy
- Abstract
Background: There is no effective treatment for methamphetamine withdrawal. This study aimed to determine the feasibility and safety of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine (MA) withdrawal., Methods: Open-label, single-arm pilot study, in an inpatient drug and alcohol withdrawal unit assessing a tapering dose of oral lisdexamfetamine dimesylate commencing at 250 mg once daily, reducing by 50 mg per day to 50 mg on Day 5. Measures were assessed daily (days 0-7) with 21-day telephone follow-up. Feasibility was measured by the time taken to enrol the sample. Safety was the number of adverse events (AEs) by system organ class. Retention was the proportion to complete treatment. Other measures included the Treatment Satisfaction Questionnaire for Medication (TSQM), the Amphetamine Withdrawal Questionnaire and craving (Visual Analogue Scale)., Results: Ten adults seeking inpatient treatment for MA withdrawal (9 male, median age 37.1 years [IQR 31.7-41.9]), diagnosed with MA use disorder were recruited. The trial was open for 126 days; enroling one participant every 12.6 days. Eight of ten participants completed treatment (Day 5). Two participants left treatment early. There were no treatment-related serious adverse events (SAEs). Forty-seven AEs were recorded, 17 (36%) of which were potentially causally related, all graded as mild severity. Acceptability of the study drug by TSQM was rated at 100% at treatment completion. Withdrawal severity and craving reduced through the admission., Conclusion: A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting., Competing Interests: Conflict of interest LSA is supported by an NDARC PhD Scholarship. MF has received unrestricted funding for research purposes from Indivior and Sequiiris. SS has received clinical research supplies from Alkermes. NE and KJS are employed by NCCRED. No other investigators have any conflicts of interest to declare., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)
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130. Correlates of treatment engagement and client outcomes: results of a randomised controlled trial of nabiximols for the treatment of cannabis use disorder.
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Mills L, Dunlop A, Montebello M, Copeland J, Bruno R, Jefferies M, Mcgregor I, and Lintzeris N
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- Australia, Bayes Theorem, Cannabidiol, Dronabinol, Drug Combinations, Humans, Male, Pain, Cannabinoids therapeutic use, Cannabis, Marijuana Abuse drug therapy, Marijuana Abuse psychology, Substance-Related Disorders
- Abstract
Introduction and Aims: There is increasing interest and evidence for the use of cannabinoid medications in the treatment of cannabis use disorder, but little examination of the correlates of successful treatment. This paper is a secondary analysis of a randomised placebo-controlled trial of nabiximols for the treatment of cannabis use disorder (CUD), aiming to identify which client and treatment characteristics impact treatment engagement and outcomes., Method: Bayesian multiple regression models were used to examine the impact of age, gender, duration of regular cannabis use, daily quantity of cannabis, cannabis use problems, self-efficacy for quitting, sleep, mental health, pain measures, and treatment group upon treatment engagement (retention, medication dose, and counselling participation) and treatment outcomes (achieving end-of-study abstinence, and a 50% or greater reduction in cannabis use days) among the 128 clients participating in the 12-week trial., Results: Among the treatment factors, greater counselling attendance was associated with greater odds of abstinence and ≥ 50% reduction in cannabis use; nabiximols with greater odds of ≥ 50% reduction and attending counselling, and reduced hazard of treatment dropout; and higher dose with lower odds of ≥ 50% reduction. Among the client factors, longer duration of regular use was associated with higher odds of abstinence and 50% reduction, and lower hazard of treatment dropout; greater quantity of cannabis use with reduced hazard of dropout, greater odds of attending counselling, and higher average dose; greater pain at baseline with greater odds of ≥ 50% reduction and higher average dose; and more severe sleep issues with lower odds of ≥ 50% reduction. Males had lower odds of attending counselling., Discussions and Conclusions: These findings suggest that counselling combined with agonist pharmacotherapy may provide the optimal treatment for cannabis use disorder. Younger clients, male clients, and clients with sleep issues could benefit from extra support from treatment services to improve engagement and outcomes., Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000103460) https://www.anzctr.org.au., (© 2022. The Author(s).)
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- 2022
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131. Trial protocol of an open label pilot study of lisdexamfetamine for the treatment of acute methamphetamine withdrawal.
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Acheson LS, Ezard N, Lintzeris N, Dunlop A, Brett J, Rodgers C, Gill A, Christmass M, McKetin R, Farrell M, Shoptaw S, and Siefried KJ
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- Double-Blind Method, Humans, Lisdexamfetamine Dimesylate adverse effects, Pilot Projects, Treatment Outcome, Alcoholism drug therapy, Amphetamine-Related Disorders drug therapy, Attention Deficit Disorder with Hyperactivity drug therapy, Central Nervous System Stimulants adverse effects, Methamphetamine adverse effects, Substance Withdrawal Syndrome drug therapy
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Introduction: Methamphetamine (MA) use disorder is an important public health concern. MA withdrawal is often the first step in ceasing or reducing use. There are no evidence-based withdrawal treatments, and no medication is approved for the treatment of MA withdrawal. Lisdexamfetamine (LDX) dimesilate, used in the treatment of attention deficit hyperactivity disorder and binge eating disorder has the potential as an agonist therapy to ameliorate withdrawal symptoms, and improve outcomes for patients., Methods: A single arm, open-label pilot study to test the safety and feasibility of LDX for the treatment of MA withdrawal. Participants will be inpatients in a drug and alcohol withdrawal unit, and will receive a tapering dose of LDX over five days: 250mg LDX on Day 1, reducing by 50mg per day to 50mg on Day 5. Optional inpatient Days 6 and 7 will allow for participants to transition to ongoing treatment. Participants will be followed-up on Days 14, 21 and 28. All participants will also receive standard inpatient withdrawal care. The primary outcomes are safety (measured by adverse events, changes in vital signs, changes in suicidality and psychosis) and feasibility (the time taken to enrol the sample, proportion of screen / pre-screen failures). Secondary outcomes are acceptability (treatment satisfaction questionnaire, medication adherence, concomitant medications, qualitative interviews), retention to protocol (proportion retained to primary and secondary endpoints), changes in withdrawal symptoms (Amphetamine Withdrawal Questionnaire) and craving for MA (visual analogue scale), and sleep outcomes (continuous actigraphy and daily sleep diary)., Discussion: This is the first study to assess lisdexamfetamine for the treatment of acute MA withdrawal. If safe and feasible results will go to informing the development of multi-centre randomised controlled trials to determine the efficacy of the intervention., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Michael Farrell as Director of NDARC has received unrestricted funding for research purposes from Indivior and Sequiiris. Steve Shoptaw has received clinical research supplies from Alkermes. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
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- 2022
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132. Diagnosing and managing patients with chronic pain who develop prescription opioid use disorder: A scoping review of general practitioners' experience.
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Wilson H, Harris-Roxas B, Lintzeris N, and Harris M
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- Analgesics, Opioid adverse effects, Drug Prescriptions, Humans, Chronic Pain drug therapy, General Practitioners, Opioid-Related Disorders drug therapy, Opioid-Related Disorders therapy
- Abstract
Background and Objectives: Prescription opioid use disorder (pOUD) is an important sequela of long-term prescribed opioids for chronic pain. General practitioners (GPs) may not systematically diagnose or manage this; however, it is unclear why., Method: This scoping review searched multiple databases to assess GPs' experience diagnosing and managing patients prescribed opioids for chronic pain who have developed pOUD., Results: The 19 included articles report high levels of GP concern regarding opioid diversion, inappropriate use, abuse, misuse, diversion, dependence and addiction. Confidence screening and detecting pOUD is mixed, and few screen systematically. The most common response is declining to prescribe rather than diagnosing and managing pOUD., Discussion: GPs experience high levels of conflict when considering potential pOUD in their patients with chronic pain prescribed opioids. Their experiences diagnosing and managing pOUD are not fully understood. Further theory-based research may help to understand this and assist future policy directions, programs and research priorities.
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- 2022
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133. Overdose and take-home naloxone in emergency settings: A pilot study examining feasibility of delivering brief interventions addressing overdose prevention with 'take-home naloxone' in emergency departments.
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Black E, Monds LA, Chan B, Brett J, Hutton JE, Acheson L, Penm J, Harding S, Strumpman D, Demirkol A, and Lintzeris N
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- Adult, Analgesics, Opioid therapeutic use, Crisis Intervention, Emergency Service, Hospital, Feasibility Studies, Female, Humans, Male, Naloxone therapeutic use, Narcotic Antagonists therapeutic use, Pharmaceutical Preparations, Pilot Projects, Drug Overdose drug therapy, Drug Overdose prevention & control, Opiate Overdose
- Abstract
Objective: Although most unintentional opioid deaths in Australia are attributed to pharmaceutical opioids, take-home naloxone (THN) programmes have to date predominantly targeted people using illicit opioids in drug treatment and harm reduction settings. We sought to examine the feasibility of delivering THN brief interventions (THN-BIs) with intranasal naloxone in EDs., Methods: This pilot feasibility study was conducted across three major metropolitan EDs in Sydney and Melbourne. ED staff were surveyed about their perspectives regarding THN before completing a 30-min training programme in THN-BI delivery. Patients presenting with opioid overdose or considered high risk for future overdose were eligible to receive the THN-BI. Staff survey responses were compared between hospitals and provider types using one-way analysis of variances. Patient demographic and clinical characteristics were extracted from medical records and compared between hospitals and overdose type using Fisher's exact test and one-way analysis of variances., Results: One hundred and twenty-two ED staff completed the survey. One hundred and ten (90.2%) agreed that EDs should provide THN-BIs, whereas 23 (19.2%) identified time constraints and 17 (12.9%) felt uncomfortable discussing overdose with patients. Fifty-seven patients received the THN-BI, with the majority (n = 50, 87.7%) having presented following opioid overdose. The median age was 44 years and 40 (71.4%) were men. Two-thirds of the overdoses (n = 31, 66.0%) were attributed to heroin with one-third (n = 16, 34%) being attributed to pharmaceutical opioids., Conclusions: ED-based delivery of THN-BIs can reach a wide range of individuals at-risk of overdose. The present study supports the feasibility of THN interventions in EDs and underscores the importance of addressing implementation barriers including staff training., (© 2022 Australasian College for Emergency Medicine.)
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- 2022
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134. Medical cannabis use in Australia: consumer experiences from the online cannabis as medicine survey 2020 (CAMS-20).
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Lintzeris N, Mills L, Abelev SV, Suraev A, Arnold JC, and McGregor IS
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- Adult, Cross-Sectional Studies, Dronabinol, Female, Humans, Male, Middle Aged, Cannabis, Hallucinogens, Medical Marijuana therapeutic use
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Background: Australia has had a framework for legal medicinal cannabis since 2016, yet prior online surveys in 2016 and 2018 indicated that most consumers continued to use illicit medical cannabis products. Regulatory data indicate an increase in the prescription of medicinal cannabis since 2019, and this survey examines consumer experiences of prescribed and illicit medical cannabis (MC) use in Australia., Methods: A cross-sectional anonymous online survey was administered September 2020 to January 2021. Recruitment via social media, professional and consumer forums, and medical practices. Participant eligibility: ≥ 18 years; used a cannabis product for self-identified medical reason(s) in the past year, and resident in Australia. Outcome measures included consumer characteristics, conditions treated, source and patterns of MC use, and perspectives on accessing MC., Results: Of the 1600 participants (mean age 46.4 ± 14.3 years, 53% male), 62.4% (n = 999) reported using only illicit and 37.6% (n = 601) used prescribed MC in the past year. MC was used on a median of 28 (IQR: 12, 28) of the past 28 days and cost $AUD 74 ± 72 weekly (median = $40, IQR: $7, $100). Prescribed participants were more likely to treat pain conditions than those using illicit MC (52% v 40%, OR = 1.7, 1.3-2.1) and less likely to treat sleep conditions (6% v 11%, OR = 0.5, 0.3-0.8), with mental health conditions also a common indication in both groups (26%, 31%). Prescribed MC was consumed predominately by oral routes (72%), whereas illicit MC was most commonly smoked (41%). Prescribed MC was 'mainly THC' (26%), 'equal THC/CBD' (40%), 'mainly CBD' (31%) and 'uncertain' (3%), while 34% of those using illicit MC were 'uncertain' of the cannabinoid profile. Cost and difficulties finding medical practitioners to prescribe remain significant barriers to accessing prescribed MC, and few (10.8%) described the existing model for accessing prescribed MC as 'straightforward or easy'., Conclusions: There has been a notable shift from illicit to prescribed MC by many consumers compared to prior surveys. Consumers using prescribed MC reported a range of advantages compared to illicit MC, including safer routes of administration, and greater certainty regarding access and composition of products., (© 2022. The Author(s).)
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- 2022
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135. Opioid agonist treatment and patient outcomes during the COVID-19 pandemic in south east Sydney, Australia.
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Lintzeris N, Deacon RM, Hayes V, Cowan T, Mills L, Parvaresh L, Harvey Dodds L, Jansen L, Dojcinovic R, Leung MC, Demirkol A, Finch T, and Mammen K
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- Analgesics, Opioid therapeutic use, Australia epidemiology, Benzodiazepines therapeutic use, Humans, Opiate Substitution Treatment, Pandemics, Quality of Life, Buprenorphine therapeutic use, COVID-19, Opioid-Related Disorders drug therapy, Opioid-Related Disorders epidemiology
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Introduction: In early 2020, many services modified their delivery of opioid treatment in response to the COVID-19 pandemic, to limit viral spread and maintain treatment continuity. We describe the changes to treatment and preliminary analysis of the association with patients' substance use and well-being., Methods: A pre-post comparison of treatment conditions and patient self-reported outcomes using data extracted from electronic medical records in the 5 months before (December 2019-April 2020) and after (May 2020-September 2020) changes were implemented in three public treatment services in South Eastern Sydney Local Health District., Results: Data are available for 429/460 (93%) patients. Few (21, 5%) dropped out of treatment. In the 'post' period there was significantly more use of depot buprenorphine (12-24%), access to any take-away doses (TAD; 24-69%), access to ≥6 TAD per week (7-31%), pharmacy dosing (24-52%) and telehealth services. There were significant reductions in average opioid and benzodiazepine use, increases in cannabis use, with limited group changes in social conditions, or quality of life, psychological and physical health. At an individual level, 22% of patients reported increases in their use of either alcohol, opioids, benzodiazepines or stimulants of ≥4 days in the past 4 weeks. Regression analysis indicates increases in substance use were associated with higher levels of supervised dosing., Discussion and Conclusions: These preliminary findings suggest that the modified model of care continued to provide safe and effective treatment, during the pandemic. Notably, there was no association between more TAD and significant increases in substance use. Limitations are discussed and further evaluation is needed., (© 2021 Australasian Professional Society on Alcohol and other Drugs.)
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- 2022
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136. Self-reported challenges obtaining ongoing prescription opioids among Australians with chronic non-cancer pain.
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Hopkins RE, Campbell G, Degenhardt L, Lintzeris N, Larance B, Nielsen S, and Gisev N
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- Analgesics, Opioid therapeutic use, Australia epidemiology, Cross-Sectional Studies, Humans, Longitudinal Studies, Practice Patterns, Physicians', Prescriptions, Self Report, Chronic Pain drug therapy, Opioid-Related Disorders drug therapy, Opioid-Related Disorders epidemiology
- Abstract
Background: Policies to address opioid-related harms include strategies to reduce opioid prescribing for new and ongoing pain management. Concerns have been raised that people with chronic non-cancer pain (CNCP) may be adversely affected by prescribing restrictions, and by involuntary tapering and cessation of opioids. We describe self-reported challenges obtaining prescription opioids among people prescribed opioids long-term for CNCP and explore associations with participant and treatment characteristics., Methods: This cross-sectional study analysed data from a longitudinal cohort study of Australians prescribed restricted opioids for CNCP. In 2018, 861 participants who took part in Year 5 follow-up and who also reported past 12-month opioid use were asked about challenges obtaining opioid prescriptions, including prescriber access-related difficulties obtaining prescriptions or having opioids tapered or ceased involuntarily. Associations between challenges and demographics, treatment characteristics including daily opioid dose as oral morphine equivalent milligrams (OME mg/day), substance use disorder (SUD), and opioid dependence were assessed., Results: Overall, 285 (31%) participants reported at least one challenge, predominantly prescriber access-related difficulties (n=177/285; 62%). Prescriber access-related difficulties were associated with younger age (adjustedOR 0.94 per year increase, 95%CI 0.93-0.96), and past 12-month pharmaceutical opioid dependence (adjustedOR 2.25, 95%CI 1.33-3.80). Involuntary opioid tapering or cessation was reported by 73 participants (26% of those reporting challenges) and was associated with lifetime SUD diagnosis (adjustedOR 2.15, 95%CI 1.15-3.90), and opioid doses of ≥200 OME mg/day (adjustedOR 2.41, 95%CI 1.18-4.88)., Conclusion: One-third of participants with CNCP reported experiencing challenges obtaining prescriptions for opioids or having their opioid medicines involuntarily reduced. Given increasing restrictions to opioid access, it is important that strategies to reduce opioid-related harms are balanced against the current treatment needs of people prescribed opioids long-term for CNCP., Competing Interests: Declarations of Interest GC, LD, BL, and SN report investigator-driven untied educational grants from Reckitt Benckiser/Indivior; LD and BL have received investigator-initiated untied educational grants from Mundipharma Limited; NL has received grants from Camurus AB; NL has received fees for advisory board attendance from Mundipharma Ltd and Chiesi Farmaceutici S.p.A; LD, BL, and SN have received research grants from Seqirus; all of these have been outside the submitted work. All other authors declare no competing interests., (Copyright © 2022. Published by Elsevier B.V.)
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137. What do general practitioners want from specialist alcohol and other drug services? A qualitative study of New South Wales metropolitan general practitioners.
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Wilson H, Schulz M, Rodgers C, Lintzeris N, Hall JJ, and Harris-Roxas B
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- Humans, New South Wales, Qualitative Research, Referral and Consultation, General Practice, General Practitioners, Substance-Related Disorders
- Abstract
Introduction: Alcohol and other drug (AOD) use is common in Australia with significant health and community impacts. General practitioners (GP) often see people with AOD use; however, there is little research to understand how specialist AOD services could assist GPs in the management of patients with AOD issues., Methods: Thirty-five GPs working in general practice in a metropolitan area in Sydney in New South Wales, Australia, participated in one of three focus groups. The groups were recorded, transcribed and thematically analysed., Results: The five themes raised by participants were: GP personal agency and interest in AOD issues; GP education and training gaps; improving pathways between GP and specialist AOD services; easier access to AOD specialist advice; and improving access to collaborative care for patients with complex AOD presentations. Participants requested education on screening, assessing, managing AOD issues, focused on alcohol, stimulants and high-risk prescription medicines. They suggested better referral processes, discharge summaries and care planning for complex presentations. Participants wanted easy access to specialist advice and suggested collaborative care assisted by experienced AOD liaison nurses., Discussion and Conclusions: Australia has several existing programs; online referral pathways and specialist phone advice, that address some of the issues raised. Unfortunately, many participants were not aware of these. GP education must be supported by multiple processes, including durable referral pathways, ready access to local specialist advice, clear communication (including patient attendance and a treatment plan), care planning and written summaries., (© 2022 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2022
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138. The Overdose Response with Take Home Naloxone (ORTHN) project: Evaluation of health worker training, attitudes and perceptions.
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Monds LA, Bravo M, Mills L, Malcolm A, Gilliver R, Wood W, Harrod ME, Read P, Nielsen S, Dietze PM, Lenton S, Bleeker AM, and Lintzeris N
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- Harm Reduction, Health Knowledge, Attitudes, Practice, Humans, Naloxone therapeutic use, Narcotic Antagonists therapeutic use, Drug Overdose drug therapy, Opioid-Related Disorders drug therapy
- Abstract
Introduction: Naloxone is a life-saving medication that reverses opioid overdose; naloxone can be provided on a 'take-home' basis so naloxone can be administered outside of the health-care setting. The Overdose Response and Take Home Naloxone (ORTHN) project established a model of care for take-home naloxone (THN) interventions across alcohol and other drug and harm reduction services in NSW, Australia. This paper evaluates the staff training and credentialing program, and examines staff attitudes and perspectives regarding the provision of THN interventions in these settings., Methods: Staff across seven services were trained through a 'train-the-trainer' credentialing model to deliver ORTHN, including naloxone supply. Staff were surveyed regarding their experience, attitudes and knowledge on THN prior to and after training, and after 6 months. At the 6 months follow up, staff were asked about the interventions they provided, barriers and enablers to uptake, and opinions regarding future rollout., Results: A total of 204 staff were trained and credentialed to provide the ORTHN intervention. Most (60%) were nurses, followed by needle syringe program workers and allied health/counsellors (32%). Linear and logistic regression analyses indicated that the training program was associated with significant improvements in staff knowledge and attitudes towards overdose and THN; however, only attitudinal improvements were maintained over time. There were high rates of staff satisfaction with the ORTHN intervention and training., Discussion/conclusions: The ORTHN program is 'fit for purpose' for broad implementation in these settings. A number of potential barriers (e.g. time, medication and staffing costs) and enablers (e.g. peer engagement, regulatory framework for naloxone supply) in implementing THN interventions were identified., (© 2022 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2022
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139. Response to Steele and Acheson.
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Lintzeris N, Jansen L, and Hayes V
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- Humans, Public Health
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- 2022
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140. Prevalence and correlates of cannabis use disorder among Australians using cannabis products to treat a medical condition.
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Mills L, Lintzeris N, O'Malley M, Arnold JC, and McGregor IS
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- Analgesics, Australia epidemiology, Bayes Theorem, Cross-Sectional Studies, Humans, Pain, Prevalence, Cannabis, Hallucinogens, Marijuana Abuse epidemiology, Medical Marijuana therapeutic use, Substance-Related Disorders
- Abstract
Introduction: Prior research has examined the prevalence and correlates of cannabis use disorder (CUD) in people who use cannabis; however, these are poorly described for people using cannabis for medical reasons., Methods: Data came from a 2018 to 2019 online, anonymous, cross-sectional survey of Australians reporting using either illicit or licit cannabis for medical reasons within the past year. Included were questions on demographics, current and lifetime patterns of cannabis use, clinical conditions for which medical cannabis was used, and individual criteria for CUD and cannabis withdrawal syndrome. Bayesian Horseshoe logistic regression models were used to identify covariates associated with meeting CUD DSM-5 conditions for any-CUD (≥2/11 criteria) and moderate-severe-CUD (≥4/11)., Results: A total of 905 participants were included in the analysis. The majority (98%) used illicit cannabis products. Criteria for any-CUD criteria were met by 290 (32.0%), and 117 (12.9%) met criteria for moderate-severe-CUD. Tolerance (21%) and withdrawal (35%) were the most commonly met criteria. Correlates with the strongest association with CUD were inhaled route of administration [odds ratio (OR) = 2.96, 95% credible interval 1.11, 7.06], frequency of cannabis use (OR = 1.24, 1.11-1.35), proportion of cannabis for medical reasons (OR = 0.83, 0.74, 0.94), frequency of tobacco use (OR = 1.10, 1.03, 1.17), age (OR = 0.75, 0.64, 0.90) and pain as main clinical indication (OR = 0.58, 0.36, 1.00)., Discussion and Conclusions: Prevalence of CUD in medical cannabis users appears comparable to 'recreational' users, with many similar correlates. CUD was associated with using cannabis to treat mental health rather than pain conditions and inhaled over other routes of administration., (© 2022 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
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- 2022
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141. Opioid-sparing effect of cannabinoids for analgesia: an updated systematic review and meta-analysis of preclinical and clinical studies.
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Nielsen S, Picco L, Murnion B, Winters B, Matheson J, Graham M, Campbell G, Parvaresh L, Khor KE, Betz-Stablein B, Farrell M, Lintzeris N, and Le Foll B
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- Analgesics, Opioid, Humans, Morphine therapeutic use, Analgesia, Cannabinoids pharmacology, Cannabinoids therapeutic use, Chronic Pain drug therapy, Opioid-Related Disorders drug therapy
- Abstract
Cannabinoid co-administration may enable reduced opioid doses for analgesia. This updated systematic review on the opioid-sparing effects of cannabinoids considered preclinical and clinical studies where the outcome was analgesia or opioid dose requirements. We searched Scopus, Cochrane Central Registry of Controlled Trials, Medline, and Embase (2016 onwards). Ninety-two studies met the search criteria including 15 ongoing trials. Meta-analysis of seven preclinical studies found the median effective dose (ED
50 ) of morphine administered with delta-9-tetrahydrocannabinol was 3.5 times lower (95% CI 2.04, 6.03) than the ED50 of morphine alone. Six preclinical studies found no evidence of increased opioid abuse liability with cannabinoid administration. Of five healthy-volunteer experimental pain studies, two found increased pain, two found decreased pain and one found reduced pain bothersomeness with cannabinoid administration; three demonstrated that cannabinoid co-administration may increase opioid abuse liability. Three randomized controlled trials (RCTs) found no evidence of opioid-sparing effects of cannabinoids in acute pain. Meta-analysis of four RCTs in patients with cancer pain found no effect of cannabinoid administration on opioid dose (mean difference -3.8 mg, 95% CI -10.97, 3.37) or percentage change in pain scores (mean difference 1.84, 95% CI -2.05, 5.72); five studies found more adverse events with cannabinoids compared with placebo (risk ratio 1.13, 95% CI 1.03, 1.24). Of five controlled chronic non-cancer pain trials; one low-quality study with no control arm, and one single-dose study reported reduced pain scores with cannabinoids. Three RCTs found no treatment effect of dronabinol. Meta-analyses of observational studies found 39% reported opioid cessation (95% CI 0.15, 0.64, I2 95.5%, eight studies), and 85% reported reduction (95% CI 0.64, 0.99, I2 92.8%, seven studies). In summary, preclinical and observational studies demonstrate the potential opioid-sparing effects of cannabinoids in the context of analgesia, in contrast to higher-quality RCTs that did not provide evidence of opioid-sparing effects., (© 2022. The Author(s).)- Published
- 2022
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142. Mood, sleep and pain comorbidity outcomes in cannabis dependent patients: Findings from a nabiximols versus placebo randomised controlled trial.
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Montebello M, Jefferies M, Mills L, Bruno R, Copeland J, McGregor I, Rivas C, Jackson MA, Silsbury C, Dunlop A, and Lintzeris N
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- Analgesics therapeutic use, Cannabidiol, Cannabinoid Receptor Agonists therapeutic use, Comorbidity, Double-Blind Method, Dronabinol, Drug Combinations, Humans, Pain drug therapy, Sleep, Treatment Outcome, Cannabis, Hallucinogens therapeutic use, Marijuana Abuse therapy, Medical Marijuana therapeutic use
- Abstract
Background: Mood, sleep and pain problems are common comorbidities among treatment-seeking cannabis-dependent patients. There is limited evidence suggesting treatment for cannabis dependence is associated with their improvement. This study explored the impact of cannabis dependence treatment on these comorbidities., Methods: This is a secondary analysis from a 12-week double-blind placebo-controlled trial testing the efficacy of a cannabis agonist (nabiximols) against placebo in reducing illicit cannabis use in 128 cannabis-dependent participants. Outcome measurements including DASS-21 (Depression, Anxiety, and Stress subscales); Insomnia Severity Index (ISI); and Brief Pain Inventory (BPI), were performed at weeks 0, 4, 8, 12 and 24. Each was analysed as continuous outcomes and as binary cases based on validated clinical cut-offs., Results: Among those whose DASS and ISI scores were in the moderate to severe range at baseline, after controlling for cannabis use, there was a gradual decrease in severity of symptoms over the course of the trial. BPI decreased significantly until week 12 and then rose again in the post-treatment period during weeks 12-24. Neither pharmacotherapy type (nabiximols vs placebo) nor number of counselling sessions contributed significant explanatory power to any of the models and were excluded from the final analyses for both continuous and categorical outcomes., Conclusions: Participants in this trial who qualified as cases at baseline had elevated comorbidity symptoms. There was no evidence that nabiximols treatment is a barrier to achieving reductions in the comorbid symptoms examined. Cannabis dependence treatment reduced illicit cannabis use and improved comorbidity symptoms, even when complete abstinence was not achieved., (Copyright © 2022. Published by Elsevier B.V.)
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- 2022
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143. Clinical Case Conference: Strategies for Transferring From Methadone to Buprenorphine.
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Hill D, Hayes V, Demirkol A, and Lintzeris N
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- Humans, Methadone therapeutic use, Patient Preference, Buprenorphine therapeutic use, Opioid-Related Disorders complications, Opioid-Related Disorders drug therapy, Substance Withdrawal Syndrome complications, Substance Withdrawal Syndrome drug therapy
- Abstract
The mainstay of treatment for opioid use disorder are medications, methadone (a full opioid agonist), or buprenorphine (a partial opioid agonist), in conjunction with psychosocial interventions. Both treatments are effective but safety, efficacy, and patient preference can lead to a decision to change from one treatment to the other. Transfer from buprenorphine to methadone is not clinically challenging; however, changing from methadone to buprenorphine is more complex. Published reports describe varied approaches to manage this transfer to both minimize patient symptoms associated with withdrawal from methadone and reduce risk of precipitating withdrawal symptoms with introduction of the partial agonist buprenorphine [Lintzeris et al. J Addict Med. 2020; in press]. There is no single approach for methadone to buprenorphine that is superior to others and no approach that is suitable for all case presentations. This case conference describes three different approaches to achieve a successful methadone to buprenorphine transfer and provides commentary on how the case may be managed based on published transfer "strategies.", Competing Interests: Duncan Hill and Apo Demirkol have no conflicts of interest to disclose. Victoria Hayes has received money from Camurus and Viiv for providing education and training sessions. Nicholas Lintzeris has served on Advisory Boards for Mundipharma, Indivior, GW Pharmaceuticals and Camurus, and has received funding for conducting research from Camurus., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Addiction Medicine.)
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- 2022
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144. Sex differences in acute cannabis effects revisited: Results from two randomized, controlled trials.
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Arkell TR, Kevin RC, Vinckenbosch F, Lintzeris N, Theunissen E, Ramaekers JG, and McGregor IS
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- Double-Blind Method, Dronabinol pharmacology, Sex Factors, Humans, Male, Female, Cannabidiol pharmacology, Cannabis
- Abstract
Some evidence suggests that males and females may differ in their responses to acute cannabis effects, including subjective drug effects and behavioural effects, and cannabinoid pharmacokinetics. This is significant given current changes to cannabis-related policies and, in consequence, increased cannabis accessibility. The present study combines data from two randomized controlled trials to investigate possible differences among males (n = 21) and females (n = 19) in the acute effects of vaporized cannabis containing 13.75 mg Δ9-tetrahydrocannabinol (THC), with and without cannabidiol (CBD; 13.75 mg). To control for differences in the timing of assessments, peak (or peak change from baseline) scores were calculated for a range of measures including subjective drug effects, cognitive performance, cardiovascular effects, and plasma concentrations of THC, CBD, and their respective primary metabolites. While THC elicited robust and significant changes in all but one outcome measure relative to placebo, relatively few sex differences were observed after controlling for BMI and plasma THC concentrations. Relative to females, males performed better overall on a divided attention task (DAT) and had higher peak plasma concentrations of 11-nor-9-carboxy-THC (11-COOH-THC). Males and females did not differ with respect to plasma concentrations of any other analyte, subjective drug effects, or cardiovascular measures. These data indicate an absence of systematic sex differences in acute cannabis effects given a moderate dose of vaporized cannabis. They do not preclude the possibility that sex differences may emerge with higher THC doses or with other commonly used routes of administration (e.g., orally administered oils or edibles)., (© 2021 The Authors. Addiction Biology published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)
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- 2022
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145. Strategies for Transfer From Methadone to Buprenorphine for Treatment of Opioid Use Disorders and Associated Outcomes: A Systematic Review.
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Lintzeris N, Mankabady B, Rojas-Fernandez C, and Amick H
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- Humans, Methadone therapeutic use, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy, Opioid-Related Disorders rehabilitation
- Abstract
Objectives: To review the currently available evidence on transfer strategies from methadone to sublingual buprenorphine used in clinical trials and observational studies of medication for opioid use disorder treatment, and to consider whether any strategies yield better clinical outcomes than others., Methods: Six medical and public health databases were searched for articles and conference abstracts. The Cochrane Central Register of Controlled Trials and the World Health Organization International Clinical Trials Registry Platform were used to identify unpublished trial results. Records were dually screened, and data were extracted and checked independently. Results were summarized qualitatively and, when possible, analyzed quantitatively., Results: Eighteen studies described transfer from methadone to buprenorphine. Transfer protocols were extremely varied. Most studies reported successful rates of transfer, even among studies involving transfer from high methadone doses, although lower pretransfer methadone dose was significantly associated with higher rate of successful transfer. Precipitated withdrawal was not reported frequently. A range of innovative approaches to transfer from methadone to buprenorphine remains untested., Conclusions: Few studies have used designs that enable comparison of different approaches to transfer patients from methadone to buprenorphine. Most international clinical guidelines provide recommendations consistent with the available evidence. However, clinical guidelines should be perceived as providing "guidance" rather than "protocols," and clinicians and patients need to exercise judgment when attempting transfers., Competing Interests: Nicholas Lintzeris has served on Advisory Boards for Mundipharma, Indivior, GW Pharmaceuticals, and Camurus, and has received funding for conducting research from Camurus. Baher Mankabady reports no conflicts of interest. Carlos Rojas-Fernandez completed the work as a paid consultant to Venebio. Halle Amick reports receipt of consulting fees from Indivior during the conduct of this review., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Addiction Medicine.)
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- 2022
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146. Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence.
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Farrell M, Shahbazi J, Byrne M, Grebely J, Lintzeris N, Chambers M, Larance B, Ali R, Nielsen S, Dunlop A, Dore GJ, McDonough M, Montebello M, Nicholas T, Weiss R, Rodgers C, Cook J, and Degenhardt L
- Subjects
- Adult, Analgesics, Opioid therapeutic use, Buprenorphine, Naloxone Drug Combination, Delayed-Action Preparations therapeutic use, Female, Heroin therapeutic use, Humans, Male, Narcotic Antagonists, Quality of Life, Buprenorphine, Opioid-Related Disorders drug therapy
- Abstract
Background: Opioid agonist treatment (OAT) is an effective intervention for opioid dependence. Extended-release buprenorphine injections (BUP-XR) may have additional potential benefits over sublingual buprenorphine. This single-arm trial evaluated outcomes among people receiving 48 weeks of BUP-XR in diverse community healthcare settings in Australia, permitting examination of outcomes when BUP-XR is delivered in standard practice., Methods: Participants were recruited from a network of specialist public drug treatment services, primary care and some private practices in three states. Following a minimum 7 days on 8-32 mg of sublingual buprenorphine (±naloxone), participants received monthly subcutaneous BUP-XR injections administered by a healthcare practitioner and completed monthly research interviews. The primary endpoint was retention in treatment at 48 weeks., Findings: Participants (n = 100) were 28% women, mean age 44 years with a long history of OAT (median 5.8 years); heroin was the most common opioid of concern (58%). Treatment retention at 24 and 48 weeks was 86% and 75%, respectively. Participants with past-month injecting drug use (OR 0.23; 95%CI: 0.09-0.61) or heroin use (OR 0.23; 95%CI: 0.08-0.65) at baseline had lower odds of being retained in treatment to 48 weeks. Reductions in multiple forms of extra-medical drug use were observed. Improvements in quality of life, participation in employment, and treatment satisfaction measures were also observed., Interpretation: This real-world implementation study of BUP-XR demonstrated high retention and treatment satisfaction. This study provides important additional data on the uptake and experience of clients, with relevance for policy makers, health service planners, administrators, and practitioners., Funding: Indivior., Trial Registration: ClinicalTrials.gov Identifier: NCT03809143., Competing Interests: Declarations of Interest This study was supported by an Externally Sponsored Collaborative Research grant from Indivior PLC (MF, BL, LD, NL, AD, RA, SN, GD, JG). In the past three years, MF and LD have received funding from Indivior, Seqirus for studies of new opioid medications in Australia. JG reports grants and personal fees from Abbvie, Camurus, Cepheid, Hologic, Indivior, Gilead Sciences, and Merck. NL has received reimbursement for participation in Advisory Boards for Mundipharma, Indivior and Chiesi Pharmaceuticals; he received funding from Camurus for a company-sponsored trial of BUP-XR. RA has received untied educational grants from Reckitt Benckiser and an untied educational grant from Mundipharma. AJD reports grants from Braeburn/Camurus AB, to conduct clinical studies with buprenorphine products and travel support to Hunter New England Local Health District, which employs AJD. He has served as an honorary on advisory boards for Mundipharma and Seqiris. GJD has received research grant funding from Gilead and Abbvie. MM has served as an honorary on advisory boards for Pfizer and AbbVieMC. JS and MB have no conflicts to declare. SN has received untied research funding from Seqirus to conduct research on prescription opioid related harms., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2022
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147. Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings.
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Dunlop AJ, White B, Roberts J, Cretikos M, Attalla D, Ling R, Searles A, Mackson J, Doyle MF, McEntyre E, Attia J, Oldmeadow C, Howard MV, Murrell T, Haber PS, and Lintzeris N
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- Analgesics, Opioid therapeutic use, Female, Humans, Male, Methadone therapeutic use, Narcotic Antagonists therapeutic use, Opiate Substitution Treatment, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy
- Abstract
Background and Aims: Opioid agonist treatment is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings world-wide. This study assessed the safety of subcutaneous slow-release depot buprenorphine in custody., Design: Open-label, non-randomized trial., Setting: Correctional centres in New South Wales, Australia., Participants: Sixty-seven men and women, aged ≥ 18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder currently serving a custodial sentence of ≥ 6 months were recruited between November 2018 and July 2019. Patients not in opioid agonist treatment at recruitment commenced depot buprenorphine; patients already stable on oral methadone treatment were recruited to the comparison arm., Intervention and Comparator: Depot buprenorphine (CAM2038 weekly for 4 weeks then monthly) and daily oral methadone., Measurements: Safety was assessed by adverse event (AE) monitoring and physical examinations at every visit. Participants were administered a survey assessing self-reported diversion and substance use at baseline and weeks 4 and 16., Findings: Retention in depot buprenorphine treatment was 92.3%. Ninety-four per cent of patients reported at least one adverse event, typically mild and transient. No diversion was identified. The prevalence of self-reported non-prescribed opioid use among depot buprenorphine patients decreased significantly between baseline (97%) and week 16 (12%, odds ratio = 0.0035, 95% confidence interval = 0.0007-0.018, P < 0.0001)., Conclusions: This first study of depot buprenorphine in custodial settings showed treatment retention and outcomes comparable to those observed in community settings and for other opioid agonist treatment used in custodial settings, without increased risk of diversion., (© 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)
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- 2022
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148. Determination of contaminants in artisanal cannabis products used for childhood epilepsy in the Australian community: A sub-analysis of the 'PELICAN' study.
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Suraev A, Benson MJ, Martin L, Lintzeris N, and McGregor IS
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- Adolescent, Australia epidemiology, Child, Child, Preschool, Humans, Cannabis, Epilepsy, Metals, Heavy analysis, Pesticides analysis
- Abstract
Despite recent approval of pharmaceutical-grade cannabis products for the treatment of childhood epilepsy, some families continue to use artisanal cannabis products as a way to manage seizures in their children. However, such products are typically of unknown composition and quality, and may therefore pose an unpredictable health risk to the child. In the present analysis, 78 samples of cannabis products collected (as part of a previous study) from families of children with epilepsy (average age 8.8 ± 4.6 years) were analyzed for heavy metals (arsenic, cadmium, lead, and mercury), residual solvents (panel of 19 solvents) and pesticides (panel of 57 pesticides). Due to small sample volumes obtained, only a subset of samples was used in each analysis. Results showed that no cannabis sample exceeded the toxicity limits for heavy metals (n = 51 samples tested). Of the 58 cannabis samples tested for residual solvents, 17 (29%) contained concentrations of ethanol or isopropanol above the generally accepted limit of 5000 parts per million. With the volumes consumed, it was thought unlikely that children were consuming hazardous amounts of residual solvents, although this could not be ruled out in every case. Most samples (n = 31 samples tested) yielded inconclusive results for the pesticides, although one sample contained concentrations of bifenthrin that were 4.9 times higher than the acceptable limit. Overall, these results highlight the need for improved access to quality-assured cannabis products and the education of doctors, patients, and artisanal manufacturers around the contaminant exposure risk in unregulated cannabis products., Competing Interests: Declaration of Competing Interest ISM is Academic Director of the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically-funded research program at the University of Sydney. He has served as an expert witness in various medicolegal cases involving cannabis and has received consulting fees from Medicinal Cannabis Industry Australia (MCIA) and Janssen. He currently acts as an advisor/consultant to Kinoxis Therapeutics, Psylo and Emyria. He reports research grants and salary support from the Australian National Health and Medical Research Council (NHMRC) and from Lambert Initiative for Cannabinoid Therapeutics. He is an inventor on patents WO2018107216A1 and WO2017004674A1, licensed to Kinoxis Therapeutics involving use of novel small molecules (non-cannabinoid) to treat addictions and social deficits. ISM also has patents WO2020102857A1 and WO2021042178A1 related to use of small molecules (non-cannabinoid) for treating weight gain and opioid withdrawal, as well as patents WO2019227167 and WO2019071302 issued, which relate to cannabinoid therapeutics. AS has received consulting fees from the Medicinal Cannabis Industry Australia (MCIA). NL has been funded to serve on Advisory Boards for Chiesi, Mundipharma and Indivior, and has received research funding from Camurus for unrelated research. All other authors have no competing financial or non-financial interests to declare., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2022
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149. Determining clinical cutoff scores for the Australian Treatment Outcomes Profile psychological health, physical health and quality of life questions.
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Mammen K, Mills L, Deacon RM, Bruno R, Dunlop A, Holmes J, Luksza J, Shakeshaft A, Farrell M, and Lintzeris N
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- Australia, Humans, Psychometrics, Reproducibility of Results, Surveys and Questionnaires, Treatment Outcome, Mental Health, Quality of Life
- Abstract
Introduction: The Australian Treatment Outcomes Profile (ATOP) is a brief instrument that measures self-reported substance use, health, and wellbeing in the previous 28 days for people in alcohol and other drug treatment. Previous studies have established the concurrent validity, inter-rater, and test-retest reliability of the tool. The current study sought to identify recommended cutoff scores for ATOP items for psychological health, physical health and quality of life that identify clients reporting clinically significant problems warranting further assessment and/or intervention, compared to cutoffs used by 'gold-standard' measures for these domains., Methods: Clients attending for treatment for problems with opioid (n = 144) or alcohol use (n = 134) completed the ATOP and comparison standardised questionnaires (Kessler-10, Short Form Survey 12 and the Personal Wellbeing Index) with a researcher. Receiver operating characteristics analysis, along with clinician perspectives, were used to recommend cutoff scores for ATOP items indicative of clinically significant problems., Results: A cutoff score of 5 or less out of 10 was identified as an optimal pragmatic cutoff for ATOP items relating to psychological health, physical health and quality of life items with regards to balancing sensitivity, specificity, and application in a treatment setting., Discussion and Conclusions: The recommended clinical cutoffs will support clinicians and treatment services to identify clients who require further assessment and follow up for their psychological health, physical health and quality of life. The current study provides further evidence for the utility of the ATOP for individual clinical review, service planning and research., (© 2021 Australasian Professional Society on Alcohol and other Drugs.)
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- 2022
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150. New Australian guidelines for the treatment of alcohol problems: an overview of recommendations.
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Haber PS, Riordan BC, Winter DT, Barrett L, Saunders J, Hides L, Gullo M, Manning V, Day CA, Bonomo Y, Burns L, Assan R, Curry K, Mooney-Somers J, Demirkol A, Monds L, McDonough M, Baillie AJ, Clark P, Ritter A, Quinn C, Cunningham J, Lintzeris N, Rombouts S, Savic M, Norman A, Reid S, Hutchinson D, Zheng C, Iese Y, Black N, Draper B, Ridley N, Gowing L, Stapinski L, Taye B, Lancaster K, Stjepanović D, Kay-Lambkin F, Jamshidi N, Lubman D, Pastor A, White N, Wilson S, Jaworski AL, Memedovic S, Logge W, Mills K, Seear K, Freeburn B, Lea T, Withall A, Marel C, Boffa J, Roxburgh A, Purcell-Khodr G, Doyle M, Conigrave K, Teesson M, Butler K, Connor J, and Morley KC
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- Australia, Humans, Practice Guidelines as Topic, Self Report, Alcoholism diagnosis, Alcoholism therapy
- Abstract
Of Recommendations and Levels of Evidence: Chapter 2: Screening and assessment for unhealthy alcohol use Screening Screening for unhealthy alcohol use and appropriate interventions should be implemented in general practice (Level A), hospitals (Level B), emergency departments and community health and welfare settings (Level C). Quantity-frequency measures can detect consumption that exceeds levels in the current Australian guidelines (Level B). The Alcohol Use Disorders Identification Test (AUDIT) is the most effective screening tool and is recommended for use in primary care and hospital settings. For screening in the general community, the AUDIT-C is a suitable alternative (Level A). Indirect biological markers should be used as an adjunct to screening (Level A), and direct measures of alcohol in breath and/or blood can be useful markers of recent use (Level B). Assessment Assessment should include evaluation of alcohol use and its effects, physical examination, clinical investigations and collateral history taking (Level C). Assessment for alcohol-related physical problems, mental health problems and social support should be undertaken routinely (GPP). Where there are concerns regarding the safety of the patient or others, specialist consultation is recommended (Level C). Assessment should lead to a clear, mutually acceptable treatment plan which specifies interventions to meet the patient's needs (Level D). Sustained abstinence is the optimal outcome for most patients with alcohol dependence (Level C). Chapter 3: Caring for and managing patients with alcohol problems: interventions, treatments, relapse prevention, aftercare, and long term follow-up Brief interventions Brief motivational interviewing interventions are more effective than no treatment for people who consume alcohol at risky levels (Level A). Their effectiveness compared with standard care or alternative psychosocial interventions varies by treatment setting. They are most effective in primary care settings (Level A). Psychosocial interventions Cognitive behaviour therapy should be a first-line psychosocial intervention for alcohol dependence. Its clinical benefit is enhanced when it is combined with pharmacotherapy for alcohol dependence or an additional psychosocial intervention (eg, motivational interviewing) (Level A). Motivational interviewing is effective in the short term and in patients with less severe alcohol dependence (Level A). Residential rehabilitation may be of benefit to patients who have moderate-to-severe alcohol dependence and require a structured residential treatment setting (Level D). Alcohol withdrawal management Most cases of withdrawal can be managed in an ambulatory setting with appropriate support (Level B). Tapering diazepam regimens (Level A) with daily staged supply from a pharmacy or clinic are recommended (GPP). Pharmacotherapies for alcohol dependence Acamprosate is recommended to help maintain abstinence from alcohol (Level A). Naltrexone is recommended for prevention of relapse to heavy drinking (Level A). Disulfiram is only recommended in close supervision settings where patients are motivated for abstinence (Level A). Some evidence for off-label therapies baclofen and topiramate exists, but their side effect profiles are complex and neither should be a first-line medication (Level B). Peer support programs Peer-led support programs such as Alcoholics Anonymous and SMART Recovery are effective at maintaining abstinence or reductions in drinking (Level A). Relapse prevention, aftercare and long-term follow-up Return to problematic drinking is common and aftercare should focus on addressing factors that contribute to relapse (GPP). A harm-minimisation approach should be considered for patients who are unable to reduce their drinking (GPP). Chapter 4: Providing appropriate treatment and care to people with alcohol problems: a summary for key specific populations Gender-specific issues Screen women and men for domestic abuse (Level C). Consider child protection assessments for caregivers with alcohol use disorder (GPP). Explore contraceptive options with women of reproductive age who regularly consume alcohol (Level B). Pregnant and breastfeeding women Advise pregnant and breastfeeding women that there is no safe level of alcohol consumption (Level B). Pregnant women who are alcohol dependent should be admitted to hospital for treatment in an appropriate maternity unit that has an addiction specialist (GPP). Young people Perform a comprehensive HEEADSSS assessment for young people with alcohol problems (Level B). Treatment should focus on tangible benefits of reducing drinking through psychotherapy and engagement of family and peer networks (Level B). Aboriginal and Torres Strait Islander peoples Collaborate with Aboriginal or Torres Strait Islander health workers, organisations and communities, and seek guidance on patient engagement approaches (GPP). Use validated screening tools and consider integrated mainstream and Aboriginal or Torres Strait Islander-specific approaches to care (Level B). Culturally and linguistically diverse groups Use an appropriate method, such as the "teach-back" technique, to assess the need for language and health literacy support (Level C). Engage with culture-specific agencies as this can improve treatment access and success (Level C). Sexually diverse and gender diverse populations Be mindful that sexually diverse and gender diverse populations experience lower levels of satisfaction, connection and treatment completion (Level C). Seek to incorporate LGBTQ-specific treatment and agencies (Level C). Older people All new patients aged over 50 years should be screened for harmful alcohol use (Level D). Consider alcohol as a possible cause for older patients presenting with unexplained physical or psychological symptoms (Level D). Consider shorter acting benzodiazepines for withdrawal management (Level D). Cognitive impairment Cognitive impairment may impair engagement with treatment (Level A). Perform cognitive screening for patients who have alcohol problems and refer them for neuropsychological assessment if significant impairment is suspected (Level A)., Summary of Key Recommendations and Levels of Evidence: Chapter 5: Understanding and managing comorbidities for people with alcohol problems: polydrug use and dependence, co-occurring mental disorders, and physical comorbidities Polydrug use and dependence Active alcohol use disorder, including dependence, significantly increases the risk of overdose associated with the administration of opioid drugs. Specialist advice is recommended before treatment of people dependent on both alcohol and opioid drugs (GPP). Older patients requiring management of alcohol withdrawal should have their use of pharmaceutical medications reviewed, given the prevalence of polypharmacy in this age group (GPP). Smoking cessation can be undertaken in patients with alcohol dependence and/or polydrug use problems; some evidence suggests varenicline may help support reduction of both tobacco and alcohol consumption (Level C). Co-occurring mental disorders More intensive interventions are needed for people with comorbid conditions, as this population tends to have more severe problems and carries a worse prognosis than those with single pathology (GPP). The Kessler Psychological Distress Scale (K10 or K6) is recommended for screening for comorbid mental disorders in people presenting for alcohol use disorders (Level A). People with alcohol use disorder and comorbid mental disorders should be offered treatment for both disorders; care should be taken to coordinate intervention (Level C). Physical comorbidities Patients should be advised that alcohol use has no beneficial health effects. There is no clear risk-free threshold for alcohol intake. The safe dose for alcohol intake is dependent on many factors such as underlying liver disease, comorbidities, age and sex (Level A). In patients with alcohol use disorder, early recognition of the risk for liver cirrhosis is critical. Patients with cirrhosis should abstain from alcohol and should be offered referral to a hepatologist for liver disease management and to an addiction physician for management of alcohol use disorder (Level A). Alcohol abstinence reduces the risk of cancer and improves outcomes after a diagnosis of cancer (Level A)., (© 2021 AMPCo Pty Ltd.)
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- 2021
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