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Background: Fatal drug overdoses have involved both xylazine and fentanyl. Xylazine is a non-opioid substance used in veterinary medicine. This study aimed to model changes in fatal xylazine-involved drug overdose deaths from 2019 to 2023 in Connecticut using overdose death data from the Office of the Chief Medical Examiner. Methods: Xylazine-involved drug overdose fatality rates were calculated by number of deaths per year per 100,000 population from 2019 to 2023. We used joinpoint regression modeling to evaluate quarterly overdose rates across age, number of drugs, and drug types with a significance level of p < 0.05. Results: From 2019 to 2023, there were 1116 xylazine-involved fatal overdoses with a cumulative rate of 31.3 deaths per 100,000. Xylazine-involved overdose death rates were significantly higher in Hispanic populations compared to both non-Hispanic White and Black populations (p < 0.05). The joinpoint analyses showed that xylazine-fentanyl mortality rates significantly increased by 0.18 per 100,000 per quarter from 2019 to 2022. Xylazine-fentanyl overdoses involving at least 4 or 5 substances significantly increased. Windham, Hartford, New London, and New Haven counties had the highest xylazine-involved death rates. Conclusion: Xylazine-fentanyl deaths increased from 2019 to 2023, and often involved multiple substances (e.g., cocaine, ethanol, benzodiazepines, and oxycodone). Results show Hispanic populations, those aged 35–49, and 50+ experienced high rates of xylazine-fentanyl overdose deaths. Vulnerable populations in Connecticut for special consideration for future intervention and local resource allocation are recommended. [ABSTRACT FROM AUTHOR]

Background: Chronic substance use contributes to reduced sleep time and REM sleep, and increased sleep latency and WASO. These effects are exacerbated by withdrawal, impact craving, and increase risk factors for relapse to substance use. Methods: This secondary analysis examined objective and subjective sleep data in individuals with comorbid alcohol and opioid use disorders (AUD and OUD) in an 8-week randomized, double-blind inpatient trial on gabapentin's subjective and physiological effects on oxycodone and alcohol alone, and their combination. Participants (n = 13; 8% female) were non-treatment-seeking individuals with OUD and AUD. Participants wore an ActiWatch Monitor nightly and completed daily sleep diaries. We examined the effects of gabapentin on sleep after nine laboratory sessions where oxycodone (0 mg, 15 mg, 30 mg), alcohol (placebo, 0.5 g/kg, 0.75 g/kg) and combined doses were administered and explored the relationship between baseline substance use and sleep. Results: Active gabapentin dosing attenuated the relationship between laboratory-administered alcohol, oxycodone, and their combinations on some objective sleep measures, but not others. Self-reported heroin and alcohol use at baseline impacted sleep outcomes throughout the inpatient trial. Discussion and Conclusion: Gabapentin may attenuate the negative effects of opioids and alcohol on sleep, though further work is needed to examine this relationship. Scientific Significance: Subjective and objective sleep outcomes are impacted by laboratory-administered doses of alcohol, oxycodone, and their combination, though patterns of results were somewhat inconsistent. More work is needed to understand safe and effective treatments for sleep disruption in those with OUD and AUD. [ABSTRACT FROM AUTHOR]

This article argues that Purdue Pharma, maker of OxyContin, is a morally insolvent corporation – its wrongdoing pervasive or central to the corporation’s operations, its actions causing grave harm, and yet accountability still seems out of reach. It further argues that Purdue helps demonstrate how criminal legal systems are not capable of holding corporations accountable for wrongdoing. For humans, being convicted of a crime often means being sent to jail, and states pay little attention to the plight of children of prisoners. For corporations, criminal legal systems focus on deterrence as a goal, largely because corporations are not capable of suffering from retributive punishments in the way that humans are. But corporate insolvency processes demonstrate that corporations can be restructured, reorganised, and liquidated. This article posits that a system of corporate moral insolvency could better respond to corporate wrongdoing – combining an inquiry-style process of fact finding with a negotiated settlement process providing those with most at stake a means to assert their interests, all while deterring future wrongdoing. [ABSTRACT FROM AUTHOR]

Background: Fentanyl has emerged as the leading cause of fatal drug overdoses in the U.S. Individuals misusing drugs may not always be aware of exposure to fentanyl. Objectives: To determine the prevalence of fentanyl use and extent of awareness of fentanyl exposure among a national sample of treatment-seeking individuals with opioid use disorder (n = 1098). Methods: Participants provided oral fluid and urine specimens, which were tested for drugs by liquid chromatography/tandem mass spectrometry. Participants also provided self-reports of fentanyl use. Results: 49.5% tested positive for fentanyl in oral fluid, urine, or both. Of those testing positive for fentanyl, 29.8% were unaware that they had been exposed to fentanyl. Participants testing positive for opioids methadone, and specifically 6-monoacetylmorphine (6-MAM), a unique metabolite of heroin, were significantly more likely to be unaware of fentanyl exposure than participants testing negative for these substances, with a similar trend for oxycodone and tramadol. Conclusions: These findings may be due to fentanyl's effect being difficult to distinguish from that of other opioids, whereas when other types of drugs are adulterated with fentanyl, the differences in effects are likely to be readily discernable. These results support the importance of expanded drug-checking services. [ABSTRACT FROM AUTHOR]

According to the Centers for Disease Control and Prevention (CDC), 100,306 drug overdose deaths occurred in the US during a 12-month period ending in April 2021. Opioids were involved in 75% of these related deaths. Opioid Use Disorder (OUD) is a constantly evolving public health crisis with potentially lethal consequences. In 2017, 900 adolescents began to misuse opioids every day. Nearly 10% of high school seniors reported using opioids nonmedically. Additionally, the incidence for hospitalizations for adolescents among children 1-19 years of age increased nearly 2-fold from 1997 to 2012. This data emphasizes the dangers associated with the increasing accessibility of pharmaceutical and non-pharmaceutical opioids, particularly for adolescents. All three of the currently FDA approved medications for OUD have shown clear efficacy in decreasing all-cause mortality in adults. It is proposed that the same effects should be seen in adolescents but limited data is present. A recent study analyzed buprenorphine and naltrexone treatment amongst OUD in adolescents between 2001-2014; only 1 in 4 youth received any medication therapy within six months of diagnosis. Adolescents under 16 were the most likely to receive medications. However, even adolescents aged 17, for whom buprenorphine is FDA approved for, were less likely to receive therapy than adults over 18 years of age. The following case report aims to demonstrate how subcutaneous extended release buprenorphine treatment can be initiated effectively as an outpatient in an adolescent with OUD. It is critical that clinicians work to expand access to pharmacotherapy for adolescents struggling with OUD to ensure proper management and reduction of opioid-related overdoses. [ABSTRACT FROM AUTHOR]

Opioid dependence has become a public health problem in several countries. A cohort study was used to assess first-time dispensed opioids, in 2012–2015, by drug type, doses, oral morphine equivalents, and diagnoses, in Sweden. First-time opioid users aged 18–64 years, previously cancer-free and opioid-naïve for at least 6.5 years, were studied. Time trends in opioid use in Sweden 2006–2021 were also studied. During the study, 617,568 patients were dispensed opioids for the first time. The crude proportion of first-time opioid users in the population was 2.7% in 2012 and 2.6% in 2015. The combination product of codeine and paracetamol was the most frequent dispensed opioid with 322,818 patients (52.3%), followed by tramadol (120,271, 19.6%) and oxycodone (104,418, 16.9%). From 2012 to 2015, tramadol as first dispensed opioid dropped from 26.5% to 13.7% and oxycodone increased from 10.0% to 24.4%. For the four most commonly dispensed opioids, the median initial dispensal ranged from 250 to 400 oral morphine equivalents. The most common indication was fracture of the lower leg during inpatient care and back pain for specialized outpatient care. Trends in dispensed opioids in Sweden show a shift from tramadol to oxycodone, but do not show an increase in total opioid use. [ABSTRACT FROM AUTHOR]

This report describes the use of subcutaneous lidocaine infusion to manage complex pain associated with checkpoint inhibitor inflammatory arthritis. In addition, the safe administration of lidocaine in the home setting is described. A 49-year-old man with metastatic melanoma to lung, right axilla and posterior chest wall on regular pembrolizumab developed checkpoint inhibitor inflammatory arthritis. Pain associated with this was unresponsive to simple analgesia, escalating opioids and adjuvant analgesics. Lidocaine infusion was used on separate occasions (inpatient unit and home setting) to gain rapid and sustained control of inflammatory pain. Inflammatory pain responded well to 2 mg/kg/h lidocaine infusion over 4 days with sustained response between infusions of up to 6 wk. Resulting in improved mobility, functional status, and overall quality of life. Lidocaine infusion should be considered as an option for analgesic management of checkpoint inhibitor inflammatory arthritis in patients for whom usual treatment is ineffective, and as an opioid-sparing intervention. [ABSTRACT FROM AUTHOR]

The opioid epidemic has created unprecedented challenges in the United States (US), including hundreds of thousands of lives lost to overdose in the past five years. Expansion of prevention and treatment for opioid use disorder (OUD) is urgently needed, as evidence-based strategies exist but many remain unable to access life-saving services. To inform school health and mental health providers, educators and school administrators about the causes and consequences of the US opioid epidemic and to provide practical solutions for engineering multi-tiered systems of support for children and families affected by the epidemic, including through opioid misuse, OUD, and opioid overdose. We review the literature on the history of and current challenges associated with the opioid epidemic in the US. The collateral damage of OUD is pervasive, impacting children and families across the US. We found no health education programs focusing on this topic in US schools, underscoring a critical need and cogent practice/policy avenue. Schools are uniquely positioned to respond to the opioid epidemic, but school health and mental health providers, educators, and other professionals who work in schools must have accurate knowledge of the opioid epidemic, understand the challenges it is causing for children and families, and be familiar with best practices in prevention and treatment. This review provides a succinct overview of the history of the opioid epidemic, examines its impacts on children and families, and provides a call to action for schools to partner in our national response. The US opioid epidemic has caused broad devastation in homes, schools, and communities across the country. Increases in mental health disorders and isolation associated with the COVID-19 pandemic have only worsened the epidemic. School health and mental health providers, along with educators and school administrators, can play a critical role in delivering prevention messages, providing screening and linkage to evidence-based services, and offering psychosocial support for children and families impacted by opioid misuse and opioid use disorder (OUD). Decreasing the stigma surrounding the opioid epidemic is also critical, and school professionals/educators are well-positioned to play a key role in stigma reduction efforts in schools and communities. There is a critical absence of health education programs in the US focusing on this topic, underscoring the need for the development and expansion of such programs. A AJHE Self-Study quiz is online for this article via the SHAPE America Online Institute (SAOI) [ABSTRACT FROM AUTHOR]

Polypharmacy is becoming increasingly troublesome in the treatment of cancer. The aim of this study was to explore the effects of concomitant polypharmacy comprising drugs that inhibit CYP3A4 and/or CYP2D6 on the oxycodone tolerability in patients with cancer. We conducted a multicenter retrospective study encompassing 20 hospitals. The data used for the study were obtained during the first 2 wk of oxycodone administration. The incidence of oxycodone discontinuation or dose reductions due to side effects and oxycodone-induced nausea and vomiting (OINV) were compared between patients not treated with either inhibitor and those treated with concomitant CYP3A4 or CYP2D6 inhibitors. The incidence of oxycodone discontinuation or dose reductions in patients treated with ≥3 concomitant CYP2D6 inhibitors (18.2%) tended to be higher than that in patients without this treatment (8.2%; p = 0.09). Moreover, the incidence of OINV in patients treated with 2 concomitant CYP3A4 inhibitors (29.8%) was significantly higher than that in patients without this treatment (15.5%; p = 0.049). Multivariate analysis showed that more than two concomitant CYP3A4 inhibitors and no concomitant use of naldemedine were independent risk factors for OINV. Concomitant polypharmacy involving CYP3A4 inhibitors increases the risk of OINV. Therefore, medications concomitantly used with oxycodone should be optimized. [ABSTRACT FROM AUTHOR]

Opioid analgesic treatment during surgery entails the risk of persistent use. Experiences of childhood adversity have been shown to increase opioid reward in preclinical models, a finding recently extended to healthy humans. We tested whether childhood adversity similarly increased opioid reward, operationalized as drug-induced feeling good and drug liking, in outpatients receiving opioids on the operating table. This observational study recruited patients entering a Norwegian hospital for an outpatient surgical procedure. An opioid intravenous opioid analgesic (remifentanil [Minto model, effect-site concentration: 5 ng/ml], or oxycodone [5 mg]) was administered in the minutes before general anesthesia. Verbal numerical ratings of feeling good and anxious were collected 1 min before, and 1–3 min after opioid infusion. Ratings of drug liking, disliking, and feelinghigh were also collected after infusion. Patients (n = 151) completed measures of childhood adversity at a later date. Regression analyses revealed a modest yet significant negative association between childhood adversity and post-opioid liking (b = −0.06, p = 0.046) but no significant effect on feeling good (b = 0.01, p = 0.690) after the pre-operative opioid dose. Exploratory analyses showed that more childhood adversity was significantly associated with higher reports of anxiety, depression, loneliness, and pain catastrophising, however not with alcohol or other drug use, or with any other subjective drug effects. Ratings of feeling good and drug liking of medically prescribed opioids given before surgery were not higher after childhood adversity, and previous findings were not conceptually replicated. The discrepancy between current and prior results may be due to the context and stress related to the impending surgery, the short duration of drug exposure, and the relatively limited levels of high childhood adversity in the current sample compared to the original study. Exploratory analysis was consistent with the possibility of a nonlinear relationship between positive opioid effects and childhood adversity scores. Future research should assess the link between childhood adversity, subjective effects, and use of the prescribed opioids after surgery. [ABSTRACT FROM AUTHOR]

From 2018 to 2021, seizures of counterfeit oxycodone pills containing non-pharmaceutical fentanyl or other novel synthetic opioids increased significantly contributing to continuing increases in overdose mortality in Northern America. Evidence suggests that counterfeit pills are distributed through cryptomarkets. This article presents data regarding the availability and characteristics of oxycodone pills advertised on one major cryptomarket between January and March 2022. Collected data were processed using a dedicated Named Entity Recognition algorithm to identify oxycodone listings and categorized them as either counterfeit or pharmaceutical. Frequency of listings, average number of pills advertised, average prices per milligram, number of sales, and geographic indicators of shipment origin and destination were analyzed. In total, 2,665 listings were identified as oxycodone. 48.2% (1,285/2,665) of these listings were categorized as counterfeit oxycodone, advertising a total of 652,699 pills (93,242.7 pills per datapoint) offered at a lower price than pharmaceutical pills. Our data indicate the presence of a large volume of counterfeit oxycodone pills both in retail- and wholesale-level amounts mostly targeting US and Canadian customers. These exploratory findings call for more research to develop epidemiological surveillance systems to track counterfeit pill and other drug availability on the Dark web environment. [ABSTRACT FROM AUTHOR]

This study aimed to understand contributing factors of stigma toward people with opioid use disorder (OUD). We conducted a randomized factorial survey with Masters in Social Work (MSW) students (n = 70). Students received four vignettes describing a person with OUD, yielding a total of 275 vignettes for analysis. We tested whether stigma differed according to the characteristics of people with OUD. We found significantly more stigmatizing attitudes toward people with OUD who 1) inject heroin versus use oxycodone and 2) do not always take buprenorphine as prescribed versus always takes buprenorphine as prescribed. These findings indicate the need for MSW training that destigmatizes heroin use and inconsistent medication usage. [ABSTRACT FROM AUTHOR]

Xtampza ER™, an oxycodone extended-release capsule (OERC), was the first long-acting opioid to feature abuse-deterrent properties and various routes of administration without pharmacokinetic alterations. The primary objective of this study was to evaluate changes in reported pain scores after initiation of or rotation to OERC from a previous opioid. Baseline scores were from patients' outpatient visits immediately before starting OERC and were compared to those at the next two follow-up visits. Secondary objectives identified variables that influenced pain scores. Methods included screening for cancer patients with outpatient OERC prescriptions seen in the palliative care clinic. Eighty-two charts were reviewed with 66 included. Overall mean pain scores at both follow-ups were lower than those at baseline (-0.7 ± 2.1; -1.1 ± 2.4). Results were statistically significant between first and second-reported pain scores versus baseline (p = 0.009; 0.012) but clinically insignificant, defined as a = 2-point change in numeric pain scores. Most patients discontinued OERC at the first or second follow-up (35; 53%), and 12.1% of patients who started OERC were prescribed OERC at the end of the study. There were no significant variables identified to influence pain scores either statistically or clinically. Further studies are needed to determine the long-term efficacy and safety in cancer palliative-care patients. [ABSTRACT FROM AUTHOR]

This study aims to evaluate the epidemiology of potential drug interactions in terminally-ill cancer patients receiving exclusively supportive care. In this cross-sectional study, during a 6-month follow-up, we considered the medical record of terminally-ill cancer patients referred to palliative care at the cancer center in Isfahan, Iran. Potential drug-drug interactions (DDIs) were assessed by Lexi-Interact ver.1.1 online software. During the study period, 133 terminally-ill cancer patients were recruited. We detected 1678 DDIs with moderate or major severity levels. Among them, 330, 219, 32, 1075, and 51 interactions were categorized in B, C, D, and X drug interactions categories, respectively. One hundred and twenty-two patients (91.73%) encountered at least one potential drug-drug interaction during the end of life care. Mechanistically, most drug-drug interactions (64.5%) were pharmacodynamics. The most frequent pharmacological class of drugs responsible for DDIs were quetiapine (91 cases), oxycodone (87 cases), and sertraline (55 cases). Interaction between oxycodone and sertraline was found to be in the top 10 detected DDIs (13.7%). Our results showed that potentially moderate or major drug-drug interactions often occur among terminally-ill cancer patients and the clinical significance of DDIs should be considered meticulously in the palliative care cancer setting. [ABSTRACT FROM AUTHOR]

Teaching critical literature appraisal is challenging. Providing a compelling clinical context using 'cinemeduation' stimulates interest in the topic. After watching the first episode of the mini-series 'Dopesick', where the scope, timeline and extent of the problem of opioid abuse are clearly seen, abstracts of the period literature strongly supporting the use of Oxycontin for use in chronic pain are shown. All were published in highly ranked medical journals. A simple paper evaluation structure is suggested. It is PPICOREAD which stands for the following questions: Who Paid for the study? What was the Population studied? What was the Intervention given in the study? What was the Control group used? What was the Outcome and was it of clinical significance to you? Was the trial Registered? Was there an Educational element for you? Was there anything Applicable to your practice? What was the Duration of the trial? Is this duration sufficient to reassure you that the trial is relevant to your practice? The very poor quality and dishonest nature of the conclusions of these papers are quickly and easily uncovered in a supervised workshop. The causes for these clear discrepancies are discussed. The devastating consequences are described. [ABSTRACT FROM AUTHOR]

Original brand extended-release (ER) oxycodone tablets (OC) for oral use were reformulated (ORF) with abuse-deterrent properties (ADP) against inhalation and injection routes in August 2010. This product transition provided an opportunity to compare "before and after" reformulation abuse trends. Our goal was to assess the change in abuse of brand oxycodone ER from before and after introduction of ORF. Change in self-reported non-oral "OxyContin" abuse in the previous 30 days during two years pre- and four years post-reformulation was assessed among adults evaluated for substance use and treatment planning using the Addiction Severity Index-Multimedia Version (ASI-MV). Comparator opioids were used to provide a frame of reference for changes in abuse due to competing population-level opioid abuse interventions and other factors unrelated to the reformulation. A proportion (PR) and abuse report dispensing ratio (ARDR) are reported because a single measure of abuse has not been identified that can optimally describe opioid abuse or changes in opioid abuse. Interrupted time-series analyses indicated an immediate decline in non-oral abuse measures post-reformulation (PR = −52.1%; ARDR = −32.2%). Significant decreases from pre- to post-reformulation in non-oral abuse overall were observed (PR [95% CI] = −30.7% [-46.9%, −9.5%]; ARDR = −29.3% [-37.5%, −20.1%]). Comparator opioids did not demonstrate similar trends over the period. Methodology applied in this study suitably assessed the effectiveness of an ADP product. Among individuals assessed for substance use, a differential decline in non-oral abuse of brand ER oxycodone was observed since introduction of ORF. [ABSTRACT FROM AUTHOR]

Hypothalamic-pituitary-adrenal (HPA) axis dynamics are disrupted by opioids and may be involved in substance abuse; this persists during withdrawal and abstinence and is associated with co-morbid sleep disruption leading to vulnerability to relapse. We hypothesized that chronic sleep restriction (SR) alters the HPA axis diurnal rhythm and the sexually dimorphic response to acute stressor during opioid abstinence. We developed a rat model to evaluate the effect of persistent sleep loss during opioid abstinence on HPA axis dynamics in male and female rats. Plasma ACTH and corticosterone were measured diurnally and in response to acute restraint stress in rats Before (control) compared to During subsequent opioid abstinence without or with SR. Abstinence, regardless of sleep state, led to an increase in plasma ACTH and corticosterone in the morning in males. There was a tendency for higher PM plasma ACTH during abstinence in SR males (p = 0.076). ACTH and corticosterone responses to restraint were reduced in male SR rats whereas there was a failure to achieve the post-restraint nadir in female SR rats. There was no effect of the treatments or interventions on adrenal weight normalized to body weight. SR resulted in a dramatic increase in hypothalamic PVN AVP mRNA and plasma copeptin in male but not female rats. This corresponded to the attenuation of the HPA axis stress response in SR males during opioid abstinence. We have identified a potentially unique, sexually dimorphic role for magnocellular vasopressin in the control of the HPA axis during opioid abstinence and sleep restriction. [ABSTRACT FROM AUTHOR]

Objective: To determine whether an inpatient post-cesarean analgesic regimen which separated oxycodone and acetaminophen resulted in less inpatient opioid use, when compared to a regimen using combination medications containing both acetaminophen and oxycodone in a cohort including patients of all gestational ages, acuity levels, and modes of operative anesthesia. Methods: This is a retrospective cohort study which was conducted at a single tertiary care center Labor and Delivery unit. Data were collected via retrospective chart review, and a total of 170 records were examined with a final N= 150. Inclusion criteria were all patients over the age of 18, and >23.0 weeks gestational age, who had a singleton or twin cesarean delivery regardless of their mode of operative anesthesia and whether or not they received intrathecal opioid at time of delivery. Exclusion criteria were pregnancies of higher-level multiples (triplets or greater), prolonged intensive care unit (ICU) stay, and patients who received both combination oxycodone-acetaminophen and separately administered oxycodone. For analysis patients were classified into two groups: the “Combined Medication” group representing patients who received combination oxycodone-acetaminophen medication only (n= 83) and the “Separate Medication” group representing patients who received oxycodone and acetaminophen separately (n= 67). Differences between the groups with respect to opioid use and acetaminophen use were assessed. Results: The primary outcome was inpatient opioid medication use per 12-h period in intravenous morphine mg equivalents (MME). Patients received an average of 4.6 ± 3.5 MME IV morphine per 12 h in the Separate Medication group and 5.7 ± 3.7 MME IV morphine per 12 h in the Combined Medication group. When controlled for several covariates, the Separate Medication group took significantly fewer MME per 12-h period (mean difference = 1.2, 95% CI: (2.3, 0.1), p= .04). There was no appreciable difference in acetaminophen utilization between groups. Conclusions: An analgesic regimen where oxycodone is ordered separately from acetaminophen is associated with reduced inpatient opioid medication use in patients of all gestational ages, acuity levels, and modes of operative anesthesia. [ABSTRACT FROM AUTHOR]

Objectives: There is a growing concern over the increased prevalence of fentanyl contaminated oxycodone pills, referred to as M30s. The current study is an examination of content on the Reddit social media site in order to understand the perceptions of and experiences with exposure to fentanyl contaminated M30 pills. Methods: Data include subreddit posts collected from January 1, 2021, to July 28, 2021, from 71 drug-related subreddits using 34 fentanyl-related search terms. A random subsample of 500 posts was examined for thematic analysis. 226 (45.2%) of posts were determined to be relevant and included in the final sample. Results: Over one-third (n = 85, 37.6%) of subreddit posts with mention of fentanyl were related to pressed M30 pills. Three emergent themes related to pressed M30 pills were identified: suspicion of contamination in oxycodone pills was pervasive (51.2%), composition of pills evoked anxiety (40%), and M30 mitigation and testing strategies (29.4%). Conclusions: Many persons on the online communities of Reddit who use drugs were aware of fentanyl contamination in the current pressed pill market. Reddit offered a space to network with others to discuss harm reduction strategies and anxieties surrounding the pervasiveness of fentanyl in the current drug market. [ABSTRACT FROM AUTHOR]

This study sought to: (1) construct and validate a composite potential opioid misuse score; and (2) compare potential opioid misuse among individuals prescribed long-term therapy on tramadol, short-acting hydrocodone or short-acting oxycodone. A retrospective cohort study was conducted using Arkansas All-Payer Claims Database (APCD; 2013–2018) linked to Arkansas Prescription Drug Monitoring Program (PDMP; 2014–2017) and state death certificate data (2013–2018). The study subjects were ambulatory, cancer-free adults with incident long-term therapy on tramadol, short-acting hydrocodone or short-acting oxycodone. The number of opioid prescribers/pharmacies, cash payment for opioid prescriptions, overlapping prescribers/pharmacies and a composite misuse score (derived from opioid prescribers/pharmacies and cash payment) were assessed in two 180 day windows as potential measures of misuse. The composite score was developed based on associations observed with opioid overdose and opioid-related injuries. A total of 17,816 (tramadol), 23,660 (hydrocodone) and 4799 (oxycodone) persons were included. The composite score had modest discrimination for overdose (c-index = 0.65). In the first 180 day period, the average composite misuse scores were 1.28 (tramadol), 1.93 (hydrocodone) and 2.18 (oxycodone). Compared to long-term hydrocodone, long-term tramadol had lower misuse (IRR [95% CI]: 0.75 [0.73–0.76]), and long-term oxycodone had higher misuse (1.09 [1.07–1.11]) in adjusted analyses. Qualitatively similar associations were observed for nearly all individual component measures of misuse. A composite measure of potential opioid misuse had modest levels of discrimination in detecting overdose. In comparison to long-term hydrocodone therapy, long-term oxycodone had higher and tramadol had lower risk of potential opioid misuse. [ABSTRACT FROM AUTHOR]

Background: Reproductive health research among women who use drugs has focused on pregnancy prevention and perinatal/neonatal outcomes, but there have been few investigations of miscarriage and abortion, including prevalence and associated factors. Methods: Using cross-sectional data from a sample of non-pregnant women receiving harm reduction services in Philadelphia in 2016–2017 we examined lifetime miscarriage and abortion (n = 187). Separately for both outcomes, we used modified Poisson regression to estimate prevalence ratios (PR) and 95% confidence intervals (CI) for associations with each correlate. We also explored correlates of reporting both miscarriage and abortion. Results: Approximately 47% experienced miscarriage, 42% experienced abortion, and 18% experienced both. Miscarriage correlates included: prescription opioid misuse (e.g., OxyContin PR 1.82, 95% CI 1.23, 2.69); 40% increase in prevalence associated with housing instability, 50% increase with survival sex, and two-fold increase with arrest. Abortion correlates included: mental health (e.g., depression PR 2.09, 95% CI 1.18, 3.71), stimulant use (e.g., methamphetamine PR 1.83, 95% CI 1.22, 2.74), and drug injection (PR 1.76, 95% CI 1.03, 3.02); partner controlling access to people/possessions, physical and emotional violence; and a two-fold increase associated with survival sex and arrest. Experiencing both reproductive outcomes was correlated with mental health, opioid and simulant use, housing instability, survival sex, and arrest. Conclusion: Miscarriage and abortion was common among women with history of drug misuse suggesting a need for expanded access to family planning, medication-assisted therapy, and social support services, and for the integration of these with substance use services. Future research in longitudinal data is needed. [ABSTRACT FROM AUTHOR]

An optimal approach for providing sufficient postpartum analgesia while minimizing the risk of opioid misuse or diversion has yet to be elucidated. Moreover, there is scant literature on the efficacy of around-the-clock (ATC) scheduled dosing of opioid analgesia compared to pro re nata (PRN; as-needed) dosing for postpartum pain management. Here we evaluate a quality improvement intervention that aimed to proactively provide pain relief with a multimodal analgesic regimen that includes oxycodone at scheduled time intervals. This new protocol stands in stark contrast to many contemporary postpartum pain management regimens in which oral opioid medications are reserved for treating breakthrough pain. Our aim was to determine how inpatient oxycodone use is affected by as-needed compared to ATC scheduled dosing of acetaminophen, ibuprofen, and low-dose oxycodone, with the option to decline any of these medications. We also sought to determine the effect of each modality on patient satisfaction with pain control. Retrospective cohort study of singleton deliveries at ≥37 weeks of gestation at a tertiary hospital from 2013 to 2016. In month 21 of the 48-month study period, a new institutional protocol for postpartum pain management was implemented which consisted of scheduled dosing of a multimodal analgesic regimen. Prior to this, patients received pain relief only as needed, by reporting elevated pain scores to nursing staff. Patients were excluded for the following: NSAID or opioid allergies, protocol deviations, transition month deliveries, history of drug abuse, positive urine toxicology, delivery with general anesthesia, prolonged hospitalization, postpartum hemorrhage, hypertensive disorders of pregnancy, incomplete records. Outcomes evaluated were the percentage of patients receiving oxycodone and mean oxycodone use per inpatient day (milligrams). Segmented regression analysis of interrupted time series was performed to estimate linear time trends of oxycodone consumption pre- and post-protocol implementation. Results of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) standardized survey were also compared before and after implementation. A total of 19,192 deliveries were included. After adjusting for confounders, a significant downward trend in the percentage of patients receiving oxycodone was noted among both cesarean (0.004% decrease per month; p <.006) and vaginal deliveries (0.005% decrease per month; p <.0001) before implementation of the scheduled pain management protocol. Among cesarean deliveries, there was no shift at the time of implementation, and no change in the slope of the trend after implementation. Among vaginal deliveries, there was an upward shift at implementation (+7.4%, p <.0001) but no change in the slope of the trend after implementation. Regardless of mode of delivery, no trend in monthly mean oxycodone consumption per day existed before or after implementation of the new protocol, and there was no shift at the time of implementation. Scheduled multimodal analgesia was associated with an improvement in HCAHPS scores for patient reported pain control after cesarean section (63 versus 71% reporting "Always" well controlled; p <.001) but had no effect after vaginal delivery. After cesarean delivery, scheduled multimodal analgesia that includes ATC dosing of acetaminophen, ibuprofen, and low-dose oxycodone, with the option to decline any of these medications, does not increase the percentage of women who receive oxycodone or mean oxycodone consumption per inpatient day compared to as-needed analgesia. After vaginal delivery, scheduled multimodal analgesia is associated with an increase in the percentage of women who receive oxycodone but no change in mean oxycodone consumption per inpatient day. [ABSTRACT FROM AUTHOR]

To evaluate the cost-effectiveness of tapentadol immediate-release (IR) versus oxycodone IR for post-operative pain after a major hip surgery. This study has been conducted using an Australian societal perspective, focusing on adult patients after a major hip surgery. A cost-effectiveness analysis was conducted using a decision-analytic model. The model incorporated drug and other resource costs, the probability of opioid-related adverse events, and quality-adjusted life months (QALM) in each treatment arm. A willingness to pay (WTP) threshold of AU$2500 was used per QALM gained. A probabilistic sensitivity analysis was conducted to examine the uncertainty of the assumptions. The primary outcome was the incremental cost-effectiveness ratio (ICER) of tapentadol IR versus oxycodone IR, expressed as Australian dollars (AU$) per QALM gained. Tapentadol IR dominated oxycodone IR, with a cost savings of AU$201 and an increase in QALM by 0.014. The ICER was −13,946 AU$/QALM (negative value attributed to numerator). In the probabilistic sensitivity analysis, 84.2% of the simulations were in favour of tapentadol IR at the WTP threshold. Tapentadol IR may be more cost-effective than oxycodone IR for the treatment of acute postoperative pain after major hip surgeries. [ABSTRACT FROM AUTHOR]

An abuse-deterrent, microsphere-in-capsule extended-release formulation of oxycodone myristate (Xtampza® ER, Collegium Pharmaceutical Inc, Canton, Massachusetts), was approved by the FDA in 2016 for the management of pain. The advantage of this formulation of oxycodone is that the microspheres can be administered via enteral tubes without compromising the long-acting formulation. This case series characterizes the experiences of five head and neck cancer patients initiated on oxycodone myristate through enteral tube administration for control of cancer-related pain. The primary outcome of patient reported subjective improvement in pain within one week occurred in all five patients. The median time to pain control was 4 days. The safety profile of oxycodone myristate was consistent with the package insert with no new findings reported. Oxycodone myristate can be an appropriate long-acting opioid analgesic option for patients requiring enteral tube administration of medications to achieve adequate cancer-related pain control. [ABSTRACT FROM AUTHOR]

Background: This study aims to compare the price difference between the official price for pharmaceutical drugs and the price when sourced from the black market in Australia. Methods: Drug prices recorded on the StreetRx database between 2014 and June 2018 were retrieved and the base pharmacy dispensed price was also retrieved from the Australian Pharmaceutical Benefits Scheme (PBS) website. The difference in Australian dollars between the street and base pharmacy dispensed prices for each mg of drug was calculated and the price mark-up per mg for each drug was compared. Results: 2704 reports were made for Australia between 2014 and 2018 on StreetRx. Buprenorphine accounted for 26% of all reports. After the number of reports for each drug was adjusted to their respective defined daily dose (DDD)/1000 persons/day bromazepam was the most commonly reported drug with 413.2 reports per DDD/1000/day, clonazepam (399.9), lisdexamphetamine (177.1) and oxycodone (138.4), respectively. The mark-up on opioids was the highest. Of the opioids, fentanyl's median price mark-up per mg was the highest (90 AUD). Conclusion: This study has shown that users of prescription medication pay a significant mark-up for those drugs on the street. This is a measure of the perceived value by those misusing drugs. [ABSTRACT FROM AUTHOR]

Short bowel syndrome is a disorder with several complications such as malnutrition and failure of drug therapy. Treatment with opioids is needed in many patients, and oral medication is preferred. However, optimal dosing is a difficult task as current guidelines are based on an intact gastrointestinal tract. Hence, the aim of this explorative case study was to assess the pharmacokinetics of orally administered oxycodone in patients with short bowel syndrome. Six patients with short bowel syndrome were administered 10 mg oral solution oxycodone after an overnight fast. Oxycodone plasma concentrations were determined over a 6-hour period. Pharmacokinetic profiles were visually inspected. Pharmacokinetic parameters: maximum plasma concentration, time of maximum concentration and area under the curve were calculated. Data were also compared to mean values obtained in healthy participants. A clinically relevant concentration of oxycodone was found in all patients, although with large inter-individual variation. The absorption fraction tended to correlate positively with total intestinal length. Additionally, preservation of some or the entire colon seemed further to increase the absorption fraction. Time of maximum concentration varied from 30 min to approximately 90 min. Oxycodone is absorbed in a clinically relevant extent in patients with short bowel syndrome, but bioavailability varies greatly between patients, which shall be taken into consideration. Absorption is related to functional small intestinal length, but preservation of colon is also beneficial. Still, optimal therapeutic dosing must be individualized, and other factors such as those related to malnutrition and motility shall also be taken into consideration. [ABSTRACT FROM AUTHOR]

Background: Electronic cigarettes (e-cigarettes) have become increasingly popular in recent years. Existing evidence indicates e-cigarettes used in isolation are less harmful than combustible cigarettes, yet emerging work has demonstrated that adults use e-cigarettes largely in combination with combustible cigarettes (i.e. dual use). Despite this data, little is understood about how exclusive and dual e-cigarette users may differ across behavioral outcomes, such as substance use dependence and behaviors among adults. Objectives: Thus, the current project examined differences in e-cigarette dependence, problematic alcohol use, cannabis use, and nonmedical prescription opioid use (e.g. methadone and oxycodone) across both exclusive and dual e-cigarette adult users. Results: Participants included 531 (53.6% female; Mage = 35.29 years, SD = 10.44) adults with past-month e-cigarette use. Dual users reported greater e-cigarette dependence, alcohol use, current cannabis use, and endorsement of nonprescription opioid use. Conclusions/Importance: Importantly, this work suggests that adults who use both combustible and e-cigarettes may constitute a group more vulnerable to experiencing problematic substance use and more severe e-cigarette dependence than exclusive e-cigarette users. [ABSTRACT FROM AUTHOR]

Objective: Pain after coronary artery by-pass (CAB) surgery is severe. Analgesic administration by mouth is unreliable until after gastrointestinal function has recovered. We evaluated the bioavailability of oxycodone co-administered with naloxone by mouth in patients after CAB surgery using either a conventional extracorporeal circulation (CECC) or off-pump surgery (OPCAB). Methods: Twenty-four patients, 50-73 years, 12 with CECC and 12 with OPCAB, were administered a 10/5mg oxycodone-naloxone controlled-release tablet by mouth on the preoperative day and for the first seven postoperative days (PODs) thereafter. Blood samples were collected up to 24 h after the preoperative administration, and then randomly either on POD1 and POD3 or on POD2 and POD4. The oxycodone concentration in plasma was analyzed using liquid chromatography-mass spectrometry. Results: On POD1 oxycodone absorption was markedly delayed in five of six patients after CECC and in all six patients after OPCAB surgery; median of tmax after CECC 630 [range 270-1420] minutes and after OPCAB 1020 [720-1410] minutes, compared to median of 120-315 min preoperatively and on POD2-POD4. The carry-over corrected AUC0-24 values on the PODs did not differ from the preoperative values, but were higher on POD3 compared with POD1 in both CECC and OPCAB groups. The rate and extent of oxycodone absorption equaled preoperative values on POD2 and onwards in patients with CAB surgery. Conclusions: Bioavailability of oxycodone by mouth was similar after CAB surgery via CECC or having OPCAB. Data indicate that POD2 is an appropriate time to start oxycodone administration by mouth after CAB surgery. [ABSTRACT FROM AUTHOR]

Objective: To investigate demographic and behavioral risk factors for non-medical use of prescription opioids. Methods: Canadian high school students taking part in the COMPASS study reported non-medical use of prescription opioids in three categories (oxycodone, fentanyl, other prescription pain relievers) in 2017/2018. Factors of interest were collected at two baselines (2016/2017; 2015/2016) and included validated demographic (age, gender, race/ethnicity, spending money), substance use (alcohol, tobacco, cannabis), and school-related (connectedness, homework completion, truancy) measures. Results: In total, 18,826 and 7,967 students were linked between 2017/2018 and 2016/2017 or 2015/2016 respectively. Use of fentanyl was least prevalent (0.7% and 1.0% respectively), with the use of oxycodone (1.7% and 1.9%) more and use of other prescription pain relievers (4.9% and 5.1%) most common. Male gender, substance use, and lack of homework completion were associated with the use of oxycodone and other prescription pain relievers. School connectedness was identified as a potential protective factor. Conclusions: Two-thirds of significant associations found were present only in one of the two models, highlighting the complexity of non-medical use of prescription opioids among youth. School connectedness may lower the risk of non-medical use of prescription opioids, indicating that a school-based focus is justified. [ABSTRACT FROM AUTHOR]

Background: The brand name Suboxone and its generic formulation buprenorphine/naloxone is a medication for treating opioid use disorder. While this medication has been shown to be effective, little research has examined the extent to which it is being prescribed and under what circumstances.Objective: This study examined patterns of prescription claims for buprenorphine/naloxone in terms of volume and associated clinical conditions.Methods: The study was conducted using a statewide database comprising pharmacy and medical claims that were covered by commercial health insurance plans in Massachusetts between 2011 and 2015. Trends in prescription volume for buprenorphine/naloxone were assessed based on the annual number of patients with a prescription for buprenorphine/naloxone. To examine clinical conditions associated with buprenorphine/naloxone prescriptions, patients' pharmacy claims were linked to their medical claims within the prior three months. For patients with common pain-related conditions, the odds they were prescribed buprenorphine/naloxone rather than oxycodone, a widely used opioid for pain management, were also examined.Results: The number of patients with a buprenorphine/naloxone prescription increased substantially during the study period, from approximately 25,000 in 2011 to over 39,000 in 2015. The most common clinical condition associated with buprenorphine/naloxone prescribing was opioid use disorder, but a substantial percentage of prescriptions were preceded by diagnoses that included pain or were for pain alone.Conclusion: A substantial increase in the number of patients with a prescription for buprenorphine/naloxone was observed. While buprenorphine/naloxone is most frequently prescribed for opioid use disorder, clinicians also appear to prescribe it for pain, particularly for patients who may be at elevated risk for opioid use disorder. [ABSTRACT FROM AUTHOR]

Dexmedetomidine is a novel, highly selective a2 adrenoceptor agonist, whereas oxycodone serves as a µ- and k-amboceptor agonist. To analyze the effects of dexmedetomidine combined with oxycodone in locally anesthetized patients undergoing transforaminal endoscopic resection of nucleus pulposus. 112 patients were evenly randomized into oxycodone group (OG), dexmedetomidine group (DG), oxycodone-dexmedetomidine combination group (ODG), and control group (CG). No significant difference among the four groups in terms of baseline information, recovery time, or atropine was found (p > 0.05). The mean arterial pressures (MAPs) and heart rates (HRs) in ODG reduced from the injection point and were dramatically lower over those in CG, and visual analog scale (VAS) scores in ODG at 1, 2, and 6 h following surgery were lower over those in other groups (p < 0.05). The combination of dexmedetomidine with oxycodone in the local anesthesia during analgesia and sedation of patients undergoing transforaminal endoscopic resection of the nucleus pulposus manifested tangible effects. Specifically, such improved perioperative inflammatory responses and controlled cellular immunity without promoting the onset of adverse reactions. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of age on the safety and tolerability of ALO-02, an abuse-deterrent opioid formulation consisting of oxycodone hydrochloride and sequestered naltrexone hydrochloride, in patients with chronic pain.Methods: Data from two clinical studies in patients with chronic low back pain or chronic non-cancer pain were analyzed. Patients aged ≥18 years who required continuous around-the-clock opioid analgesia for an extended period were grouped into ≥65 years and <65 years age groups. Treatment-emergent adverse events (TEAEs), use of concomitant medications, clinical laboratory measurements, and occurrences of opioid withdrawal using reported adverse events (AEs) and Clinical Opiate Withdrawal Scale (COWS) scores assessed safety. Data pooling was employed for the titration and maintenance phases of both studies.Results: Respectively 805 and 436 patients received ≥1 dose of ALO-02 in the titration and maintenance phases; 121 (15.0%) and 83 (14.6%) patients, respectively, were aged ≥65 years in the titration and maintenance phases. Average doses of ALO-02 were lower in the older patients in both phases. Incidences of TEAEs were comparable between age groups in both phases and generally lower in the maintenance phase. Concomitant medications were taken more often by patients aged ≥65 years. Incidences of potentially clinically significant laboratory results were low in both phases with no clinically important differences between age groups. There were few reports of opioid withdrawal events as assessed by reported AEs and COWS scores. One patient aged ≥65 years experienced an AE of opioid withdrawal.Conclusions: The safety and tolerability of ALO-02 is similar in those aged ≥65 years and those aged <65 years with chronic pain.ClinicalTrials.gov identifiers: NCT01571362, NCT01428583. [ABSTRACT FROM AUTHOR]

This study deals with a simple and precise analytical method development and validation of a comprehensive high performance liquid chromatography method for estimation of Edetate disodium (EDTA) in liquid formulations. The effective chromatographic separation of EDTA was achieved with a X Bridge C-8 column with isocratic elution of mobile phase composed of buffer, methanol and water (175:90:675 v/v/v). The buffer used in mobile phase contained 0.06 % of tetra butyl ammonium hydroxide and adjusted pH to 7.5 ± 0.05 with 86 % of ortho phosphoric acid. The HPLC instrument flow rate was 2.0 mL min−1 and UV-detector wavelength was set 259 nm for the quantification of EDTA. The column oven temperature was 45°C. The derivatization of EDTA was carried out using 1 % copper acetate solution to form a UV active chromophore group. Proved the robustness of the method by using Design of Experiments study. The correlation coefficient for EDTA was >0.9998 and linearity range was found to be 25-75 μg mL−1. The mean recovery values were found to 98.3 (50 % level), 98.8 (100 % level) and 98.4 (150 % level). Further, specificity of the current method was proved by separating the placebo peaks. The proposed validated HPLC method was successfully applied for the determination of EDTA in Oxycodon HCl oral solutions. [ABSTRACT FROM AUTHOR]

Conjugation with the tripeptide glutathione (GSH) is a common mechanism of detoxification of many endogenous and exogenous compounds. This phenomenon typically occurs through the formation of a covalent bond between the nucleophilic free thiol moiety of GSH and an electrophilic site on the compound of interest. While GSH adducts have been identified for many licit drugs, there is a lack of information on the ability of drugs of abuse to adduct GSH. The present study utilized a metabolic assay with GSH as a nucleophilic trapping agent to bind reactive drug metabolites formed in situ. Extracted ion MS spectra were collected via LC-QqQ-MS/MS for all potentially significant ions and examined for fragmentation common to GSH-containing compounds, followed by confirmation of adduction and structural characterization performed by LC-QTOF-MS/MS. In addition to the two positive controls, of the 14 drugs of abuse tested, 10 exhibited GSH adduction, with several forming multiple adducts, resulting in a total of 22 individual identified adducts. A number of these are previously unreported in the literature, including those for diazepam, naltrexone, oxycodone and Δ9-THC. [ABSTRACT FROM AUTHOR]

Background: Tapentadol may allow greater pain relief with reduced "opioid load" compared to oxycodone. Its use has not been studied in the obstetric population. The objective of this study was to compare the efficacy and side effect profile of tapentadol with oxycodone in patients who received spinal anesthesia for elective cesarean section. The trial was registered with EU Clinical Trials Register with CT number 2016-001621-33.Methods: This was a multicenter, randomized controlled trial. Randomized patients (n = 68) received either 50 mg tapentadol or oxycodone 10 mg 12 hourly postoperatively. The primary endpoint was the sum of pain intensity difference over the first 48 hours of treatment (SPID48). Secondary outcomes included time to rescue medications, SPID36, total pain relief (TOTPAR) scores, patient satisfaction scores, sum of total pain relief and pain intensity difference (SPRID) scores, time to rescue medications and side effects experienced. An analysis of covariance model with baseline pain intensity score as a covariate was used for statistical analysis.Results: There was no significant difference in the primary endpoint of SPID48 with adjusted mean difference -11.45 (95% CI -35.35, 12.45) p = .34). Oxycodone showed significantly greater SPID36 scores compared to tapentadol with increased time to rescue medication. Side effects experienced were similar between groups.Conclusion: Tapentadol did not provide superior pain control or improved tolerability compared to oxycodone post cesarean section. Results should be interpreted however with consideration of administration of intrathecal opioids to all patients in this study and debate over the optimal dose of tapentadol for acute pain. [ABSTRACT FROM AUTHOR]

Background: Interest in tianeptine as a potential drug of abuse is increasing in the United States. We performed a retrospective study of calls to the New York State Poison Control Centers (PCCs) designed to characterize one state's experience with tianeptine. Methods: Data were gathered from existing records utilizing the poison center data collection system, Toxicall® entered between 1 January 2000 through 1 April 2017. Information regarding patient demographics, reported dose and formulation of tianeptine, reported coingestants, brief narrative description of the case, disposition, and case outcome was collected. Results: There were nine reported cases of tianeptine exposure. Seven were male with a mean age of 27. Three reported therapeutic use of tianeptine and five reported intentional abuse. One case was an unintentional pediatric exposure. Doses were reported in three cases; 12.5 mg in a pediatric unintentional exposure, and 5 and 10 g daily in the two reports of intentional abuse. Of note, five patients complained of symptoms consistent with opioid withdrawal. In one of two cases in which naloxone was administered, an improvement in mental status and the respiratory drive was noted. Outcomes reported in Toxicall® were minor in two cases, moderate in five cases, major in one case, and not reported in one case. Conclusions: These cases, reported to the New York State PCCs should alert readers to the potential for tianeptine abuse, dependence, and withdrawal. [ABSTRACT FROM AUTHOR]

The prescription opioid crisis in the United States is among the worst human-caused public health disasters in modern history, with over 500,000 dead and by some estimates almost 5% of the American population 'misusing' these drugs. This article supplies some unusual resources for understanding that crisis and the way it inherits a legacy of empire, now transfigured for a corporate age. From the museums funded by the sale of these drugs to the British-led Opium Wars to the present-day racialised dimensions of the epidemic, much can be gained from dwelling with its tangled and haunted complexities. The article concludes with a consideration of Susan Buck-Morss's reading of Walter Benjamin's meditations on the aestheticisation of politics in an age of what she calls capitalist anaesthetics. [ABSTRACT FROM AUTHOR]

Background: Problems with self-reported drug use include difficulties with recall and recognition as well as the desire to respond to questions in a socially desirable manner. Various methods have been developed to improve and/or validate estimates based on direct questioning of individuals regarding their substance use. For this study, we were interested in validating self-reported use of: 1) tobacco, 2) marijuana, and 3) other substances (i.e., heroin, cocaine, opiates, oxycodone, benzodiazepines, methamphetamine, phencyclidine, and barbiturates) employing urinalysis among inmates who participated in a randomized controlled trial of a smoking abstinence intervention in a tobacco-free prison located in the northeastern United States. Methods: Two-hundred and seven men and women with a mean age of 34.9 (standard deviation = 9.0) completed questions regarding their substance use on a 7-day Timeline Follow-Back and provided urine specimens three weeks following prison release. Results: Self-reported tobacco and marijuana use were highly consistent with urine drug testing in terms of overall agreement and Kappa (93.7% and.804 for tobacco, respectively; and 90.3% and.804 for marijuana, respectively); however, consistency was much lower for other drug use grouped together (62.7% and.270). Discussion: Although some former inmates may not accurately report substance use, our findings indicate that they are in the minority, suggesting that self-report is valid for tobacco and marijuana use but much less so for other drugs grouped together. Future research should be conducted with a larger and more diverse sample of former inmates to establish the generalizability of our findings from this study. [ABSTRACT FROM AUTHOR]

Background: A large and growing body of research and news media reports have documented the recent opioid crisis, which is linked to the emergence of the “Oxy epidemic” in the late 1990s and early 2000s. Since then, oxycodone drugged driving has increased, but spatial characteristics are unknown. Methods: This research analyzes 3,396 locations of oxycodone positivity in drivers involved in fatal traffic crashes from the Fatality Analysis Reporting System (FARS), 2001-2016. Results: There is a consistent pattern of nonrandom spatial clusters of oxycodone drugged driving during the period, as expected. Conclusion: Traffic fatality data are useful in identifying areas for targeted public health and safety interventions. [ABSTRACT FROM AUTHOR]

Objectives: There is an epidemic of nonmedical and extra-medical use opioid abuse, addiction, and overdose. Extended-release oxycodone (OxyContin®), a prescription opioid pain reliever, was reformulated in 2010 to deter its abuse. The aim of this study was to assess changes in the onset of abuse of OxyContin and other opioids among young people and adults after reformulation of OxyContin with abuse-deterrent properties.Methods: The study population was U.S. residents ≥ 12 years sampled in National Surveys on Drug Use and Health (NSDUH), 2004 to 2015, with subsample of 12-21-year-olds. Nonmedical and extra-medical use is the NSDUH proxy for abuse. Confidential audio-computer-assisted self-interviews were assessed. Age-specific incidence of nonmedical and extra-medical use of OxyContin and other prescription opioids were estimated year by year. Interrupted-time-series and age-period-cohort analyses were analyzed.Results: Interrupted-time-series analysis showed a lower incidence of OxyContin nonmedical and extra-medical use after 2010 reformulation compared to the counterfactual predicted by the trend before 2010. No such difference was seen for other prescription opioids for all ages, although a lower incidence was also observed for other prescription opioids among 12-21-year-olds. Among 12-21-year-olds, a robustly lower incidence was found in 2012 compared to 2010 for OxyContin after holding constant age and cohort effects, whereas no robust difference was observed for other prescription opioids. The results showed 137,500 fewer newly incident cases of OxyContin nonmedical and extra-medical use per year.Conclusions: This study provides evidence supporting the role of OxyContin reformulation in the reduction of onset of OxyContin nonmedical and extra-medical use. [ABSTRACT FROM AUTHOR]

Objective: To examine the laxative prescriptions in hospital inpatients with cancer and non-cancer pain on oxycodone compared to oxycodone plus naloxone combination. Design: Retrospective case note review. Setting: A palliative care inpatient unit and a general medical ward in a large tertiary referral hospital. Participants: Eighty-four patients receiving oxycodone or combination oxycodone/naloxone on general medical (45 patients) and palliative care wards (39 patients). Main outcome measures: The primary recorded outcomes were regular opioid dose (milligrams per day) and number of prescribed laxatives (type, doses, and frequency per day). Results: Sixty-three (75%) patients in the study were on at least one laxative. In the general medicine inpatients, those on combined oxycodone/naloxone received on average 3.7 laxative doses per day compared to the oxycodone patients receiving 1.6 doses a day. In the palliative medicine population, both groups received a similar number of laxatives, despite the oxycodone/naloxone patients being on lower opioid doses. Conclusion: This retrospective study of hospital inpatients with cancer and non-cancer pain found that laxative use was not reduced in those on combined oxycodone/naloxone compared to oxycodone alone, suggesting that despite the interpretations of the clinical trials in the phase IV setting, the addition of naloxone had no effect on reducing laxative use. [ABSTRACT FROM AUTHOR]

Background: Ibogaine is a monoterpene indole alkaloid used in medical and nonmedical settings for the treatment of opioid use disorder. Its mechanism of action is apparently novel. There are no published prospective studies of drug use outcomes with ibogaine.Objectives: To study outcomes following opioid detoxification with ibogaine.Methods: In this observational study, 30 subjects with DSM-IV Opioid Dependence (25 males, 5 females) received a mean total dose of 1,540 ± 920 mg ibogaine HCl. Subjects used oxycodone (n = 21; 70%) and/or heroin (n = 18; 60%) in respective amounts of 250 ± 180 mg/day and 1.3 ± 0.94 g/day, and averaged 3.1 ± 2.6 previous episodes of treatment for opioid dependence. Detoxification and follow-up outcomes at 1, 3, 6, 9, and 12 months were evaluated utilizing the Subjective Opioid Withdrawal Scale (SOWS) and Addiction Severity Index Composite (ASIC) scores, respectively.Results: SOWS scores decreased from 31.0 ± 11.6 pretreatment to 14.0 ± 9.8 at 76.5 ± 30 hours posttreatment (t = 7.07, df = 26, p < 0.001). At 1-month posttreatment follow-up, 15 subjects (50%) reported no opioid use during the previous 30 days. ASIC Drug Use and Legal and Family/Social Status scores were improved relative to pretreatment baseline at all posttreatment time points (p < .001). Improvement in Drug Use scores was maximal at 1 month, and subsequently sustained from 3 to 12 months at levels that did not reach equivalence to the effect at 1 month.Conclusion: Ibogaine was associated with substantive effects on opioid withdrawal symptoms and drug use in subjects for whom other treatments had been unsuccessful, and may provide a useful prototype for discovery and development of innovative pharmacotherapy of addiction. [ABSTRACT FROM AUTHOR]

Objective: Treatment with prolonged-release oxycodone/naloxone (PR OXN) has been shown to improve opioid induced constipation (OIC) in constipated patients. This publication reports on a real-life observational study investigating the efficacy of PR OXN with regard to bowel function in patients switching to PR OXN from WHO step 1, step 2 and step 3 opioids.Methods: Patients with chronic pain experiencing insufficient pain relief and/or unacceptable side effects were switched to PR OXN and monitored in this observational study with respect to efficacy regarding bowel function and efficacy regarding pain relief in comparison with previous analgesic therapy. A patient was considered a responder with respect to efficacy if this assessment was "slightly better", "better" or "much better" compared with previous therapy. Bowel function index, pain intensity, quality of life, laxative medication use, and safety analgesic were also evaluated.Results: A total of 1338 patients (mean [SD] age 64.3 [14.9], 63% female) were observed for 43 [3-166] days (median [range]) during treatment with PR OXN. Overall response rate regarding bowel function efficacy was 82.5%. Patients with symptoms of constipation at study entry obtained a clinically relevant improvement of the bowel function index (BFI) within the first 2 weeks of PR OXN treatment. Non-constipated patients at study entry maintained normal bowel function despite switching to treatment with the opioid PR OXN.Conclusion: In conclusion, treatment with PR OXN results in a significant and clinically relevant improvement of bowel function. During the observation of the treatment with PR OXN patients reported an improvement of quality of life (QoL). More interestingly, non-constipated patients maintained a normal bowel function, showing prevention of constipation despite the use of an opioid. [ABSTRACT FROM AUTHOR]

This paper examines the discursive and material construction of the ongoing US opioid epidemic. It argues that the epidemic cannot be understood apart from the reciprocal relation of cultural and economic processes that have made possible the formation of a market for prescription painkillers. Through an analysis of the articulation and interaction of medical, cultural, political, and market discourses, the author shows how these have been mobilized within a network of actors and institutions in ways that govern the economic life of opioid products. Dramatic transformations in the domain of pain management have coincided with shifting attitudes toward drug use in popular culture and transformations in health and regulatory policy to orchestrate the materiality of an enormous market for opioid products and make intelligible the problem of a nationwide ‘epidemic’ of opioid use and abuse. [ABSTRACT FROM AUTHOR]

Objective:To assess efficacy and safety of tapentadol prolonged release (PR) for moderate-to-severe chronic osteoarthritis knee pain. Methods:Patients (n = 990) were randomized (1:1:1) to tapentadol PR, oxycodone controlled release (CR; reference compound for assay sensitivity), or placebo for a double-blind 3-week titration and 12-week maintenance period. Primary efficacy end-points were change from baseline in average pain intensity at week 12 of maintenance (US end-point) and over the entire maintenance period (non-US end-point) with “last observation carried forward” as imputation method for missing scores. Results:Both primary end-points were not significantly different for tapentadol PR nor for oxycodone CR vs placebo at week 12 (least squares [LS] mean difference = –0.3 [95% CI = –0.61–0.09];p = 0.152 and 0.2 [95% CI = –0.16–0.54];p = 0.279, respectively) and over the maintenance period (LS mean difference = –0.2 [95% CI = –0.55–0.07];p = 0.135 and 0.1 [95% CI = –0.18–0.44];p = 0.421, respectively). Considerably more patients receiving tapentadol PR than oxycodone CR completed the trial (58.3% vs 36.6%). This is consistent with better results with tapentadol PR on the overall health status (PGIC) compared to oxycodone CR. Indeed, respectively, 56% and 42.5% rated at least “much improved” at the end of treatment. Incidences of gastrointestinal adverse events were higher for both active treatments compared to placebo. Tapentadol PR was associated with a better gastrointestinal tolerability profile with incidences of constipation (17.9% vs 35%) and of the composite of nausea and/or vomiting (23.8% vs 46.8%) significantly lower vs oxycodone CR (p < 0.001). Conclusions:The study did not demonstrate assay sensitivity. The finding that both primary end-points for tapentadol PR were not met can, thus, not be interpreted. Tapentadol PR was better tolerated than oxycodone CR, largely due to fewer gastrointestinal side-effects. [ABSTRACT FROM PUBLISHER]

Objective: To compare efficacy and safety of tapentadol prolonged-release (PR) and oxycodone-controlled release (CR) in moderate-to-severe chronic osteoarthritis knee pain.Methods: Data from two double-blind, randomized, placebo- and oxycodone CR-controlled phase 3 studies with a 3-week titration period and 12-week controlled dose adjustment maintenance period were pooled. Primary efficacy end-points were change from baseline in average pain intensity at week 12 (US end-point) and over the entire maintenance period (non-US end-point).Results: A total of 2,010 patients were assessed. For both primary end-points, tapentadol PR was significantly more effective than oxycodone CR (LS mean difference of -0.41 [95% CI = -0.65, -0.16; p = 0.001] at week 12 and -0.35 [95% CI = -0.58, -0.12; p = 0.003] over 12 weeks of maintenance [last observation carried forward]). Significantly better outcomes than for oxycodone CR were also observed for patient global impression of change, both Short Form-36 component scores, and EuroQoL-5Dimensions health status index (all p < 0.001). Relative risk for vomiting, constipation, nausea, somnolence, and pruritus was lower for tapentadol PR than for oxycodone CR. A higher proportion of oxycodone CR patients discontinued treatment (64% vs 42.2% for tapentadol PR); time to treatment discontinuation due to an adverse event was significantly shorter for oxycodone CR (p < 0.001).Conclusions: The analyses suggest that tapentadol PR provided superior pain relief and a more improved overall health status than oxycodone CR in a large patient population with moderate-to-severe chronic osteoarthritis pain. Compared to oxycodone CR, tapentadol PR showed a more favorable tolerability profile with better gastrointestinal tolerability. [ABSTRACT FROM AUTHOR]

The article presents several studies related to medicine that appeared is different periodical. It mentions a study regarding the role of signaling protein in the development of addiction-related behaviors acts as a positive modulator of oxycodone. It states a study related to analgesic use and risk of hearing loss in women. It also mentions about the announcement made by Drug Enforcement Administration (DEA) reagrding renewal registration.

Objective:The aim of this work was the development of mucoadhesive sublingual films, prepared using a casting method, for the administration of oxycodone. Materials and methods:A solvent casting method was employed to prepare the mucoadhesive films. A calibrated pipette was used to deposit single aliquots of different polymeric solutions on a polystyrene plate lid. Among the various tested polymers, hydroxypropylcellulose at low and medium molecular weight (HPC) and pectin at two different degrees of esterification (PC) were chosen for preparing solutions with good casting properties, capable of producing films suitable for mucosal application. Results and discussion:The obtained films showed excellent drug content uniformity and stability and rapid drug release, which, at 8 min, ranged from 60% to 80%. All films presented satisfactory mucoadhesive and mechanical properties, also confirmed by a test on healthy volunteers, who did not experience irritation or mucosa damages. Pectin films based on pectin at lower degrees of esterification have been further evaluated to study the influence of two different amounts of drug on the physicochemical properties of the formulation. A slight reduction in elasticity has been observed in films containing a higher drug dose; nevertheless, the formulation maintained satisfactory flexibility and resistance to elongation. Conclusions:HPC and PC sublingual films, obtained by a simple casting method, could be proposed to realize personalized hospital pharmacy preparations on a small scale. [ABSTRACT FROM AUTHOR]

Introduction: As a consequence of greater prescription opioid utilization, there has been the parallel increase in misuse, abuse, and overdose, which are serious risks. Associated new formulations may be safer. Areas covered: The introduction of abuse-deterrent opioid formulations and continuous programs to improve opioid prescribing practices may limit the opioid abuse and its consequences. Oxycodone extended release capsules are an extended-release (ER), microsphere-in-capsule abuse-deterrent-formulation designed to retain its extended-release properties following tampering or misuse (e.g., chewing, crushing). Studies have reported that this preparation is efficacious in patients with low back pain, less attractive for illicit use, and an option for patients who have difficulty swallowing and erroneously crush their medication. Expert commentary: Preliminary data regarding oxycodone extended release capsules are encouraging. However, more data in different populations are necessary to confirm initial observations, and comparison should be performed with active substances. [ABSTRACT FROM PUBLISHER]

Each year for nearly two decades, the Pain & Policy Studies Group (PPSG) has received from the International Narcotics Control Board, the global monitoring body for the implementation of the United Nations international drug control conventions, consumption data for six principal opioids used to treat moderate and severe pain: fentanyl, hydromorphone, methadone, morphine, oxycodone, and pethidine. To provide these statistics to a wider audience, PPSG developed an extensive section of its Web site featuring these data in the form of global, regional, and individual country graphs. In recent years, PPSG developed and launched three new interactive Web features for exploring opioid consumption data and generating hypotheses about patterns of opioid consumption. In July 2016, PPSG announced the addition of a new tool on its Web site to explore opioid consumption data: custom consumption graphs for opioid medicines. This tool allows users to select, customize, and create charts of the opioid consumption data and download them for use in presentations or publications. PPSG encourages colleagues to use these tools to explore and study these data to inform their work to improve the accessibility and availability of these important medicines. [ABSTRACT FROM AUTHOR]