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Abstract Background HIV disproportionately impacts people who experience incarceration. Incarceration represents an opportunity to engage in HIV prevention care for individuals who often experience a number of barriers accessing health services in the community. The development of evidence-based practices promoting pre-exposure prophylaxis for HIV prevention (PrEP) is crucial for ending the HIV epidemic within this highly marginalized population. However, PrEP research within carceral facilities has been limited and is hampered in part by the lack of ethical guidance on conducting HIV prevention research in this unique setting where incarcerated individuals are categorized as a vulnerable population requiring specific protections. This lack of knowledge is particularly striking when considering the lack of input from incarcerated individuals themselves on the responsible conduct of research, which is critical to understanding ways to ensure participant autonomy while avoiding coercive practices in research activities. Methods In order to gain a better understanding of ethical approaches to the conduct of HIV prevention research among incarcerated individuals, we conducted qualitative interviews with 21 incarcerated men who reported injecting drugs and met clinical criteria for PrEP use. The interview topics included HIV knowledge, PrEP knowledge, stigma, and perceptions related to ethical research practices. Results Themes identified included how forced abstinence during incarceration can negatively affect research participation, the importance of participant comfort as it relates to ensuring autonomy in decision making, a desire for person centred approaches in research activities, study staff characteristics impacting participant experience, and perceptions of carceral staff as members of research teams. Conclusions The results of this study indicate that conducting research focused on improving PrEP use in a carceral environment has support among those experiencing incarceration. However, researchers should place the participant experience at the center of research protocol development.

Background: Smoking prevalence among U.S. adults experiencing homelessness is ≥70 %. Interventions are needed to address persisting tobacco disparities. Methods: Adults who smoked combustible cigarettes (CC) daily (N=60) were recruited from an urban day shelter and randomly assigned to an e-cigarette switching intervention with or without financial incentives for carbon monoxide (CO)-verified CC abstinence (EC vs. EC+FI). All participants received an e-cigarette device and nicotine pods during the first 4 weeks post-switch; and those in the EC+FI group also received escalating weekly incentives for CC abstinence during the same period. Key follow-ups were conducted at 4- and 8-weeks post-switch. Results: Participants were predominantly male (75 %), 50 % were racially/ethnically minoritized, with an average age of 48.8 years. Descriptive analyses indicated that CC smoking abstinence rates among EC and EC+FI were 3.3 % vs. 13.3 % at 4 weeks (8.3 % overall) and 10.0 % vs. 13.3 % at 8 weeks (11.7 % overall) in the intent-to-treat analyses (missing considered smoking). Among those who completed follow-ups (51.7 % and 45.0 % at 4- and 8-weeks), CC abstinence rates in EC and EC+FI were 6.3 % vs. 26.7 % at 4 weeks (16.1 % overall) and 21.4 % vs. 30.8 % at 8 weeks (25.9 % overall). EC+FI participants reported fewer days of smoking, more days of e-cigarette use, and greater reductions in CO at 4-week follow-up. Most participants reported a high likelihood of switching to e-cigarettes (67.7 %). Conclusion: E-cigarette switching with financial incentives for CC cessation is a promising approach to tobacco harm reduction among adults accessing shelter services. Refinements are needed to improve engagement.

Summary: Background: India has the highest incidence worldwide of smokeless tobacco (SLT)-associated oral cancer, accounting for nearly 70% of all SLT users globally. Nicotine and tobacco-specific N-nitrosamines (TSNA) play critical roles in the addictive and carcinogenic potential, respectively, of SLT products. Our group has previously reported substantial variability in nicotine and TSNA levels across a small SLT product sample in India, calling for systematic surveillance. However, there is no information available on the current levels of these constituents in Indian SLT. Methods: We analysed 321 samples representing 57 brands of eight popular types of manufactured SLT products purchased from five local markets in Mumbai, India between August, and September 2019. The sampling locations were Mumbai Central, Kurla, Thane, Vashi, and Airoli. Product pH, moisture content, total and unprotonated (biologically available) nicotine, and TSNA levels were measured at the Advanced Centre for Treatment, Research, and Education in Cancer (ACTREC) in Mumbai. Findings: Total nicotine content ranged from 0.45 to 35.1 mg/g across products. The unprotonated nicotine fraction contributed 0.1–100% of the total nicotine content. The carcinogenic TSNA levels ranged 0.06–76 ug/g for N′-nitrosonornicotine (NNN), 0.02–19.2 ug/g for 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), and 0.01–6.51 ug/g for 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL). Consistent with our previous study, we observed substantial variations across different brands of the same product type. Interpretation: This is the most extensive and the first within-country study to report brand-specific nicotine and TSNA levels in SLT products marketed in Mumbai, India. Our results show that levels of these constituents remain extremely variable across Indian SLT and are strikingly high in many products. Enhanced public education and continued efforts to reduce SLT use prevalence in India are critical for reducing the global burden of SLT-associated morbidity and mortality. Regulation of nicotine and TSNA levels in SLT products should be considered. Funding: This work was supported by the National Institutes of Health (USA) grant R01-TW010651 and, in part, by grants R01-CA180880 and R50-CA211256. The LC-MS/MS analysis was supported in part by XII Plan project funding from the Department of Atomic Energy, Government of India.

Abstract Background Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping. Methods Design: Double-blind, randomized, parallel-group, placebo-controlled trial. Setting: The study took place at a University-run smoking cessation center. Participants: People who exclusively use ECs daily and intend to quit vaping. Intervention: A total of 140 subjects were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) plus counseling or placebo treatment (administered twice daily, for 12 weeks) plus counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. Main outcomes and measures: The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. Results CAR was significantly higher for varenicline vs placebo at each interval: weeks 4–12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25–5.68], P = 0.011); weeks 4–24, 34.3% for varenicline with counseling and 17.2% for placebo with counseling (OR = 2.52, 95% CI = [1.14–5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related. Conclusions The findings of the present RCT indicate that inclusion of varenicline in a vaping cessation program for people who use electronic cigarettes and intending to quit may result in prolonged abstinence. These positive findings establish a benchmark of intervention effectiveness, may support the use of varenicline combined with counseling in vaping cessation programs, and may also help guiding future recommendations by health authorities and healthcare providers. Trial registration The study has been registered in EUDRACT with Trial registration ID: 2016-000339-42.

Background and Aims: Medications for opioid use disorder (MOUD) are highly effective in improving treatment outcomes and reducing overdose. Concerns about interrupted access to critical MOUD services led to expansion of telemedicine services during the COVID-19 pandemic in the US. The current study tested the hypothesis that telemedicine usage and healthcare coverage would be significantly associated with access to MOUD in the early phase of the COVID-19 pandemic. Design: A cross-sectional online survey was administered to a non-probability sample from June 18-July 19, 2020 using the Amazon Mechanical Turk platform. Setting: Northeastern United States during the early phase of the COVID-19 pandemic. At the time of the survey, federal regulators had waived the longstanding requirement for in-office visits for MOUD prescription receipt and provided guidance on increasing third-party payer reimbursement rates for telehealth visits in order to mitigate barriers to care associated with COVID-19 safety guidelines. Participants: Individuals 18 years or older residing in Connecticut, Massachusetts, New Jersey, New York, or Rhode Island were eligible to complete the survey. The analytic sample was participants who reported using opioids not as prescribed by a physician in the past seven days. Measurements: Demographics, telemedicine usage, and healthcare coverage were assessed as explanatory variables. The primary outcome was whether participants reported ability to access MOUD in the past four weeks. Findings: In this sample of individuals who used illicit opioids in the past week (N = 191), one in two individuals who utilized telehealth or had healthcare coverage were able to access MOUD, whereas only one in five of their respective counterparts who did not have telehealth access or healthcare coverage were able to access these medications. Conclusions: Telemedicine and healthcare coverage were associated with greater MOUD access early in the COVID-19 pandemic, when barriers to care were high. Such findings speak to the importance of not only extending but also formalizing temporary policy changes instituted during the pandemic to allow MOUD prescribing via telemedicine.

The U.S. Department of Housing and Urban Development (HUD) required all Public Housing Authorities to become smokefree in July 2018, following an 18-month implementation period that began February 2017. The HUD rule included all combustible tobacco products; e-cigarettes were not included. This purpose of this study is to characterize e-cigarette use overall and initiation after the implementation of the smokefree rule among tobacco users living in public housing. Data were collected from 396 adult (18+ years) current tobacco users at the time of rule implementation residing in the District of Columbia Housing Authority between July 2018 and November 2021. Measures include e-cigarette use, age of initiation, reasons for e-cigarette use, e-cigarette use susceptibility (among non-users), and sociodemographic characteristics. Descriptive and crosstab statistics were calculated to characterize e-cigarette use. Nearly-one-quarter of tobacco users reported lifetime use of e-cigarettes (24 %, n = 95) and 4.8 % (n = 19) indicated past 30-day e-cigarette use. Of the lifetime users, twenty-two (23.2 %) initiated their use after the smoke-free rule went into effect, with only two of those residents indicating they did so because of the rule. Of those who never used an e-cigarette, 23.5 % (n = 70) indicated being curious about e-cigarettes and 10.7 % (n = 40) said they may use e-cigarettes in the next year. Results indicate low use of e-cigarette products and low uptake due to the rule. Few tobacco users who never used e-cigarettes indicated intentions to use. Results suggest that omitting e-cigarettes from the HUD rule has not led to significant use of these products in this sample.

Background: The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Methods: The current study is comparing the efficacy of optimized (OPT) versus enhanced usual care (UC) for smoking cessation in African Americans (AA) who smoke cigarettes. AAs who smoke (n = 392) are randomized 1:1 to OPT or UC. Participants in both groups receive 7 sessions of smoking cessation counseling and18-weeks of pharmacotherapy with long-term follow-up through Week 26. OPT participants receive nicotine patch and up to two pharmacotherapy adaptations to varenicline and bupropion plus patch based on carbon monoxide verified smoking status (≥6 ppm) at Weeks 2 and 6. UC participants receive patch throughout the duration of treatment. We hypothesize that OPT will be more effective than UC on the primary outcome of biochemically verified abstinence at Week 12. Discussion: If effective, findings could broaden the scope of tobacco dependence treatment and move the field toward optimization strategies that impro ve abstinence for AA who smoke. Trial registration: NCT03897439.

Background: Smoking rates are exceptionally high among adults experiencing homelessness (AEH). Research is needed to inform treatment approaches in this population. Methods: Participants (n=404) were adults who accessed an urban day shelter and reported current smoking. Participants completed surveys regarding their sociodemographic characteristics, tobacco and substance use, mental health, motivation to quit smoking (MTQS), and smoking cessation treatment preferences. Participant characteristics were described and compared by MTQS. Results: Participants who reported current smoking (N=404) were primarily male (74.8%); White (41.4%), Black (27.8%), or American Indian/Alaska Native (14.1%) race; and 10.7% Hispanic. Participants reported a mean age of 45.6 (SD=11.2) years, and they smoked an average of 12.6 (SD=9.4) cigarettes per day. Most participants reported moderate or high MTQS (57%) and were interested in receiving free cessation treatment (51%). Participants most frequently selected the following options as among the top 3 treatments that offered the best chance of quitting: Nicotine replacement therapy (25%), money/gift cards for quitting (17%), prescription medications (17%), and switching to e-cigarettes (16%). Craving (55%), stress/mood (40%), habit (39%), and being around other smokers (36%) were frequently identified as the most challenging aspects of quitting. Low MTQS was associated with White race, lack of religious participation, lack of health insurance, lower income, greater cigarettes smoked per day, and higher expired carbon monoxide. Higher MTQS was associated with sleeping unsheltered, cell phone ownership, higher health literacy, more years of smoking, and interest in free treatment. Discussion: Multi-level, multi-component interventions are needed to address tobacco disparities among AEH.

The COVID-19 pandemic has impacted individuals around the world, creating unprecedented challenges. Due to lockdowns and social distancing measures, many people have turned to contactless modes of obtaining alcohol and other substances (e.g., home delivery). This study investigated associations between alcohol and cannabis use before and during the initial months of the COVID-19 pandemic and factors associated with use. An online, cross-sectional survey with a non-probability sample (N = 1126) was conducted in Northeast states during June-July 2020. Outcomes examined prevalence of alcohol and cannabis use for the overall sample and predictors of use in individuals who used substances. In the overall sample, we found that alcohol and cannabis use decreased from before to during the pandemic. For individuals who drank alcohol, higher pre-pandemic drinking, mid-range household income, and obtaining alcohol through home delivery were associated with higher alcohol drinking during the pandemic. For individuals who used cannabis, higher pre-pandemic cannabis use and obtaining cannabis through home delivery were associated with higher cannabis use during the pandemic. Overall, from before to during the pandemic, we found a decrease in the proportion of individuals who used substances and no changes in quantity for individuals who continued to use substances. Home delivery was associated with greater use of alcohol and marijuana, supporting a need for further research on risk factors for heavier substance use.

Abstract Nicotine is inactivated by the polymorphic CYP2A6 enzyme to cotinine and then to 3′hydroxycotinine. The Nicotine Metabolite Ratio (NMR; 3′hydroxycotinine/cotinine) is a heritable nicotine metabolism biomarker, varies with sex and ancestry, and influences smoking cessation and disease risk. We conducted sex-stratified genome-wide association studies of the NMR in European American (EA) and African American (AA) smokers (NCT01314001, NCT00666978). In EA females (n = 389) and males (n = 541), one significant (P

Introduction Smokeless tobacco (ST) remains poorly regulated in Bangladesh. This study describes the prevalence and trends of ST use in Bangladesh, presents ST-related disease burden, identifies relevant policy gaps, and highlights key implications for future policy and practice for effective ST control in Bangladesh. Methods We analyzed secondary data from the two rounds (2009 and 2017) of The Global Adult Tobacco Survey, estimated ST-related disease burden, and conducted a review to assess differences in combustible tobacco and ST policies. In addition, we gathered views in a workshop with key stakeholders in the country on gaps in existing tobacco control policies for ST control in Bangladesh and identified policy priorities using an online survey. Results Smokeless tobacco use, constituting more than half of all tobacco use in Bangladesh, declined from 27.2% (25.9 million) in 2009 to 20.6% (22 million) in 2017. However, in 2017, at least 16947 lives and 403460 Disability-Adjusted Life Years (DALYs) were lost across Bangladesh due to ST use compared to 12511 deaths and 324020 DALYs lost in 2010. Policy priorities identified for ST control have included: introducing specific taxes and increasing the present ad valorem tax level, increasing the health development surcharge, designing and implementing a tax tracking and tracing system, standardizing ST packaging, integrating ST cessation within existing health systems, comprehensive media campaigns, and licensing of ST manufactures. Conclusions Our analysis shows that compared to combustible tobacco, there remain gaps in implementing and compliance with ST control policies in Bangladesh. Thus, contrary to the decline in ST use and the usual time lag between tobacco exposure and the development of cancers, the ST-related disease burden is still on the rise in Bangladesh. Strengthening ST control at this stage can accelerate this decline and reduce ST related morbidity and mortality.

Abstract Background Electronic cigarettes are a harm reduction strategy for individuals who smoke cigarettes who cannot or do not want to quit using FDA-approved cessation methods. Identifying perceived facilitators and barriers to switching among people who smoke cigarettes is critical to optimizing health impact. This is particularly important for the most dominant e-cigarette device, nicotine salt pod electronic cigarettes. We investigate the experience using pod electronic cigarettes among African American and Latinx individuals who smoke, the two largest racial/ethnic minority groups who experience significant health disparities. Methods From July 2018 to May 2019, adults who smoked cigarettes, age 21 + (N = 114; M age = 44.6, 59.6% male, 52.6% African American from Kansas City, 47.4% Latinx from San Diego) received JUUL-brand electronic cigarettes (referred to hereafter as JUUL) for 6 weeks and answered interview questions at week six. We inquired what they liked and disliked about using JUUL, what helped with switching and made switching difficult, future intentions for continued JUUL use, and how JUUL compared to past smoking reduction methods. Responses were coded into themes by independent raters. Theme frequencies were analyzed separately by race/ethnicity and week 6 use trajectory (exclusive JUUL use, dual JUUL and cigarette use, exclusive cigarette use). Results Clean/smell was the aspect of using JUUL most commonly liked (23%), followed by convenience (19%). Coughing/harshness was a more common barrier to switching for African American (44%) than Latinx (9%), and for continuing cigarette use (56%) than for those who exclusively switched or dually used JUUL and combustible cigarettes (15–21%). Most (78% African American; 90% Latinx) reported that the benefits of using JUUL outweighed barriers, and this varied by JUUL use trajectory: 94% exclusive switch, 86% dual use, and 42% continued cigarette use. The majority said they would continue using JUUL to replace cigarettes (83% African American; 94% Latinx) and that JUUL worked better than other methods to reduce cigarettes (72%). Conclusion African American and Latinx individuals who smoked experience using pod electronic cigarettes was generally positive. Understanding facilitators and impediments to switching to electronic cigarettes among racial/ethnic minority people who smoke can inform harm reduction interventions and reduce tobacco-related health disparities. Trial Registration ClinicalTrials.gov Identifier: NCT03511001 posted April 27, 2018.

Abstract Background Children are vulnerable to the effects of second-hand smoke exposure. Creating smoke-free homes is an effective strategy to limit exposure. We developed a smoke-free intervention (SFI) using children as a catalyst for change and teaching skills to negotiate a smoke-free home. In this paper, we present the process evaluation conducted within a pilot trial. Methods This was a mixed-methods study comprising qualitative interviews and quantitative fidelity assessment of SFI delivery. Interviews in the six intervention schools were conducted with six headteachers and 12 teachers. These explored experiences of delivering the SFI, perceived impact, barriers and facilitators to success, and ideas for improvement and for scaling up. The data were analysed using framework analysis. Delivery of the SFI was observed and fidelity scores calculated. Results The SFI was acceptable to headteachers and teachers. Fidelity scores ranged from 27/40 to 37/40. Didactic components were more fully implemented than interactive components. Time to complete the sessions, timing in the school day and school calendar were key challenges. Embedding the SFI into the curriculum was a potential solution. Conclusions These findings provide useful information to finalise the content and delivery and inform the scale-up of the SFI for our definitive trial, which is now underway. Trial registration ISRCTN68690577

Abstract Background Missing data are common in tobacco studies. It is well known that from the observed data alone, it is impossible to distinguish between missing mechanisms such as missing at random (MAR) and missing not at random (MNAR). In this paper, we propose a sensitivity analysis method to accommodate different missing mechanisms in cessation outcomes determined by self-report and urine validation results. Methods We propose a two-stage imputation procedure, allowing survey and urine data to be missing under different mechanisms. The motivating data were from a tobacco cessation trial examining the effects of the extended vs. standard Quit and Win contests and counseling vs. no counseling under a 2-by-2 factorial design. The primary outcome was 6-month biochemically verified tobacco abstinence. Results Our proposed method covers a wide spectrum of missing scenarios, including the widely adopted “missing = smoking” imputation by assuming a perfect smoking-missing correlation (an extreme case of MNAR), the MAR case by assuming a zero smoking-missing correlation, and many more in between. The analysis of the data example shows that the estimated effects of the studied interventions are sensitive to the different missing assumptions on the survey and urine data. Conclusions Sensitivity analysis has played a crucial role in assessing the robustness of the findings in clinical trials with missing data. The proposed method provides an effective tool for analyzing missing data introduced at two different stages of outcome assessment, the self-report and validation time. Our methods are applicable to trials studying biochemically verified abstinence from alcohol and other substances.

Education regarding the health effects associated with tobacco use has made important progress worldwide over the last few decades. Still, tobacco remains a significant cause of cancer and other diseases. As a result, significant worldwide morbidity and mortality is still attributable to tobacco use in modern times. Research into tobacco products, the carcinogens they contain, and how users metabolize them is an important benefit to the advancement of research aimed at reducing harm associated with tobacco use. This review summarizes the use of this type of research to study tobacco users’ risk of developing cancer, especially head and neck cancer. In addition, we discuss the use of tobacco research to provide support for increasing levels of federal regulation of tobacco products. Level of Evidence 4.

Nondaily smoking is becoming common in young adults and there appear to be different characteristics associated with past month smoking frequency among nondaily smokers. The present study examines behavioral and psychosocial correlates of smoking among subgroups of nondaily college student smokers ( N = 80; 18–25 years of age) attending a large, public university. Nondaily smokers were categorized based on the frequency of days smoked in the past month and were divided into two subgroups: 1–5 days and 6–29 days. A quarter of nondaily smokers considered themselves as a smoker and significantly more 6–29 nondaily smokers were identified as a smoker and smoked more cigarettes per day (CPD). Almost half (45%) of nondaily smokers have attempted to quit smoking completely and 71% of the 6–29 nondaily smokers reported significantly higher quit attempts. The 6–29 nondaily smokers had significantly higher perceived risk related to smoking. Self-efficacy to abstain from smoking was significantly higher for 1–5 nondaily smokers. These results suggest heterogeneity among subgroups of nondaily college student smokers exists in a number of behavioral and psychosocial factors. Prevention and cessation strategies may be improved by considering frequency of nondaily smoking and targeting subgroups differently.

Objective: To determine home smoking restrictions (HSR) predictors among African American light smokers (smoke <10 cigarettes per day). Methods: Data were obtained from a clinical trial testing the efficacy of nicotine gum and counseling among 755 African American light smokers. Results: Forty percent reported adopting HSR at week 26. Implementing HSR increased with higher baseline confidence to quit (P<0.0001) and female gender (P=0.019) and decreased with older age (P=0.016) and reduced confidence to quit between baseline and week 26 (P<0.0001). Conclusions: Confidence to quit, gender, and age are important factors to incorporate into interventions enhancing the adoption of HSR. [ABSTRACT FROM AUTHOR]

Abstract Background Despite multiple recommendations and strategies implemented at a national and international level, cigarette smoking, alcohol consumption, and cannabis use during pregnancy remains high in most countries. The objective of this study was to examine key stakeholders’ perception of the treatment interventions adopted in Spain, to identify political, organizational and personal factors associated with successful implementation, and to propose strategies for improvement. Methods A qualitative study with a phenomenological approach was conducted in 2022. The target groups were: (1) clinical decision makers in the field of addiction science, (2) health professionals who carry out treatment interventions, and (3) pregnant individuals who use tobacco, alcohol or cannabis. Two focus groups and eight in-depth interviews were conducted, recorded, and transcribed. Exploratory analysis and inductive open coding was performed, codes were merged into categories, and subcategories were identified. Results The analysis resulted in 10 subcategories which were further merged into three main categories: (1) Degree of adoption and utility of treatment interventions implemented; (2) Needs and demands with respect to the organization of treatment interventions; and, (3) Personal barriers to and facilitators for treatment. Respondents reported that despite multiple national and regional cessation initiatives, treatment interventions were rarely adopted in clinical practice. Health care administrators demanded reliable records to quantify substance use for better planning of activities. Health care professionals advocated for additional time and training and both echoed the importance of integrating cessation interventions into routine prenatal care and creating in-house specialized units. The difficulty in quitting, lack of awareness of risk for foetus and child and the controversial advice were identified as barriers by pregnant individuals. Conclusions Consistent with previous work, this study found that cessation strategies implemented by the health authorities are not effective if they are not accompanied by organizational and behavioral changes. The current study identifies a set of factors that could be pivotal in ensuring the success of treatment interventions targeting tobacco, alcohol and cannabis use among pregnant individuals.

BackgroundVarenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy. ObjectiveThis study examined the effects of combined varenicline and oral NRT and smartphone medication reminders on pharmacotherapy adherence and smoking abstinence among adults enrolled in smoking cessation treatment. MethodsA 2×2 factorial design was used. Participants (N=34) were randomized to (1) varenicline + oral NRT (VAR+NRT) or varenicline alone (VAR) and (2) smartphone medication reminder messages (REM) or no reminder messages (NREM) over 13 weeks. Participants assigned to VAR+REM received varenicline reminder prompts, and those assigned to VAR+NRT+REM also received reminders to use oral NRT. The other 2 groups (VAR+NREM and VAR+NRT+NREM) did not receive medication reminders. Participants were not blinded to intervention groups. All participants received tobacco cessation counseling. Smartphone assessments of smoking as well as varenicline and NRT use (if applicable) were prompted daily through the first 12 weeks after a scheduled quit date. Descriptive statistics were generated to characterize the relations between medication and reminder group assignments with daily smoking, daily varenicline adherence, and daily quantity of oral NRT used. Participants completed follow-up assessments for 26 weeks after the quit date. ResultsParticipants were predominantly White (71%), and half were female (50%). On average, participants were 54.2 (SD 9.4) years of age, they smoked an average of 19.0 (SD 9.0) cigarettes per day and had smoked for 34.6 (SD 12.7) years. Descriptively, participants assigned to VAR+NRT reported more days of smoking abstinence compared to VAR (29.3 vs 26.3 days). Participants assigned to REM reported more days of smoking abstinence than those assigned to NREM (40.5 vs 21.8 days). Participants assigned to REM were adherent to varenicline on more days compared to those assigned to NREM (58.6 vs 40.5 days), and participants assigned to VAR were adherent to varenicline on more days than those assigned to VAR + NRT (50.7 vs 43.3 days). In the subsample of participants assigned to VAR+NRT, participants assigned to REM reported more days where ≥5 pieces of NRT were used than NREM (14.0 vs 7.4 days). Average overall medication adherence (assessed via the Medication Adherence Questionnaire) showed the same pattern as the daily smartphone-based adherence assessments. ConclusionsPreliminary findings indicated that smoking cessation interventions may benefit from incorporating medication reminders and combining varenicline with oral NRT, though combining medications may be associated with poorer adherence. Further study is warranted. Trial RegistrationClinicalTrials.gov NCT03722966; https://classic.clinicaltrials.gov/ct2/show/NCT03722966

BackgroundSubstance use is a risk factor for COVID-19 infection and adverse outcomes. However, reasons for elevated risk for COVID-19 in substance users are not well understood. ObjectiveThe aim of this study was to evaluate whether alcohol or other drug use is associated with adherence to Centers for Disease Control and Prevention (CDC) guidelines for COVID-19 mitigation. Preregistered analyses tested the hypothesis that greater use of alcohol and other drugs would be associated with lower CDC guideline adherence. A secondary objective was to determine whether substance use was associated with the likelihood of COVID-19 testing or outcome. MethodsA cross-sectional web-based survey was administered to a convenience sample recruited through Amazon’s Mechanical Turk platform from June 18 to July 19, 2020. Individuals aged 18 years or older and residing in Connecticut, Massachusetts, New Jersey, New York, or Rhode Island were eligible to participate. The exposure of interest was past 7-day use of alcohol, cigarettes, electronic cigarettes, cannabis, stimulants, and nonmedical opioids. The primary outcome was CDC guideline adherence measured using a scale developed from behaviors advised to reduce the spread of COVID-19. Secondary outcomes were likelihood of COVID-19 testing and a positive COVID-19 test result. All analyses accounted for the sociodemographic characteristics. ResultsThe sample consisted of 1084 individuals (mean age 40.9 [SD 13.4] years): 529 (48.8%) men, 543 (50.1%) women, 12 (1.1%) other gender identity, 742 (68.5%) White individuals, 267 (24.6%) Black individuals, and 276 (25.5%) Hispanic individuals. Daily opioid users reported lower CDC guideline adherence than nondaily users (B=–0.24, 95% CI –0.44 to –0.05) and nonusers (B=–0.57, 95% CI –0.76 to –0.38). Daily alcohol drinkers reported lower adherence than nondaily drinkers (B=–0.16, 95% CI –0.30 to –0.02). Nondaily alcohol drinkers reported higher adherence than nondrinkers (B=0.10, 95% CI 0.02-0.17). Daily opioid use was related to greater odds of COVID-19 testing, and daily stimulant use was related to greater odds of a positive COVID-19 test. ConclusionsIn a regionally-specific, racially, and ethnically diverse convenience sample, adults who engaged in daily alcohol or opioid use reported lower CDC guideline adherence for COVID-19 mitigation. Any opioid use was associated with greater odds of COVID-19 testing, and daily stimulant use was associated with greater odds of COVID-19 infection. Cigarettes, electronic cigarettes, cannabis, or stimulant use were not statistically associated with CDC guideline adherence, after accounting for sociodemographic covariates and other substance use variables. Findings support further investigation into whether COVID-19 testing and vaccination should be expanded among individuals with substance-related risk factors.

Background The prevalence of waterpipe tobacco smoking has been steadily increasing worldwide. Whereas cigarette smoking dependence and withdrawal scales have been developed and used extensively, this is not the case for waterpipe smoking. Our objective was to explore correlates of the Mood and Physical Symptoms Scale (MPSS), a withdrawal scale, and smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) among waterpipe smokers in South-East Asia. Methods MPSS and LWDS-11 were translated for use in a sample of Pakistani adults taking part in a double-blind, placebo-controlled randomised trial evaluating the efficacy of varenicline for abstinence among waterpipe smokers. Participants included adults using waterpipe on a daily basis who were willing to quit. A total of 510 participants were randomised. The scales were administered at baseline and at week 25, the last follow-up that was just completed on May 23, 2017. Results Among the 510 trial participants, 249 (49%) participants used only waterpipe for tobacco smoking whereas the other 261 (51%) used cigarettes as well. At baseline and week 25, respectively, the MPSS was completed by 501 (98.2%) and 475 (93%), whereas the LWDS-11 was completed by 505 (99%) and 475 (93%). Conclusions Complete findings will be reported at 'The 17th World conference on Tobacco or Health' in Cape Town for the first application of LWDS-11 and MPSS Scale among waterpipe tobacco smokers in Pakistan. The application of these scales in Pakistan will inform whether they can be used in practice to assess the extent of dependency and withdrawal symptoms in South-East Asia.

Background Hookah tobacco smoking has increased worldwide yet there is little evidence for the efficacy of pharmacological therapies to achieve abstinence among hookah smokers. Our objective was to assess the efficacy of varenicline when added to behavioural support for hookah tobacco cessation. Methods In 2016, we conducted a double-blind, placebo controlled, randomized trial in Pakistan enrolling 510 daily hookah users who were willing to quit. All participants received behavioural support and either varenicline or placebo at randomisation. The primary outcome was 25 weeks continuous abstinence biochemically verified by a carbon monoxide level of < 10 ppm. Results Among the 510 trial participants, 429 (84%) were male and 81 (16%) female; 249 (49%) smoked only hookah and 261 (51%) smoked both hookah and cigarettes. 21 participants withdrew from treatment mainly due to adverse events. We recently completed the last follow-up (25 weeks) on May 23 rd , 2017 with a 93% (475/510) retention rate. The data will remain blinded for treatment allocation until the primary analysis is complete. [Trial Flow Chart] Conclusions We will report our primary outcome results at the '17th World conference on Tobacco or Health' in Cape Town for the first ever trial of varenicline among hookah smokers. The findings of this pharmacotherapy trial will have major implications for knowledge translation, practice and policy regarding hookah tobacco use.

Tracie C Collins1,2, David Nelson3, Jasjit S Ahluwalia1,21Department of Medicine, Division of General Internal Medicine, University of Minnesota Minneapolis, MN, USA; 2Center for Health Equity, University of Minnesota Medical School, Minneapolis, MN, USA; 3Minneapolis VA Medical Center, Center for Chronic Disease Outcomes Research, University of Minnesota, Minneapolis, MN, USABackground: We sought to identify risk factors associated with mortality following surgery for peripheral arterial disease (PAD).Methods: We evaluated the association between levels of control of atherosclerotic risk factors and time to mortality following either lower extremity bypass surgery or lower extremity amputation using Cox proportional hazards regression.Results: Among 796 patients with PAD (defined by an ankle-brachial index [ABI] < 0.9), 230 (28.9%) underwent an operation for PAD (136, lower-extremity bypasses; 111, lower-extremity amputations). Participants were followed for up to six years after their diagnosis of PAD. A total of 107 (46.5% of the 230) died during the period of follow-up. Factors associated with mortality following lower extremity bypass surgery included age 70 years and older hazard ratio [HR] 1.88; 95% confidence interval [CI]: 1.01–3.51) and of African American race (HR 1.94; 95% CI: 1.04–3.62). Renal insufficiency was significantly associated with mortality following lower extremity amputation (HR 2.19; 95% CI: 1.16–4.13). Conclusion: Our data provide information on preoperative risk variables to consider when assessing long-term mortality in persons with PAD who are undergoing surgery for PAD.Keywords: risk factors, mortality, bypass surgery, ankle-brachial index

CYP2A6 metabolizes nicotine to its primary metabolite cotinine and also mediates the metabolism of cotinine to trans-3'-hydroxycotinine (3HC). The ratio of 3HC to cotinine (the "nicotine metabolite ratio", NMR) is an in vivo marker for the rate of CYP2A6 mediated nicotine metabolism, and total nicotine clearance, and has been associated with differences in numerous smoking behaviors. The clearance of 3HC, which affects the NMR, occurs via renal excretion and metabolism by UGT2B17, and possibly UGT2B10, to 3HC-glucuronide. We investigated whether slower 3HC glucuronidation alters NMR, altering its ability to predict CYP2A6 activity and reducing its clinical utility.Plasma NMR, three urinary NMRs, three urinary 3HC glucuronidation phenotypes and total nicotine equivalents were examined in 540 African American smokers. The UGT2B17 gene deletion and UGT2B10*2 were genotyped.The UGT2B17 gene deletion, but not UGT2B10*2 genotype, was associated with slower 3HC glucuronidation (indicated by three 3HC-glucuronidation phenotypes), indicating its role in this glucuronidation pathway. However, neither lower rates of 3HC glucuronidation, nor the presence of a UGT2B17 and UGT2B10 reduced function allele, altered plasma or urinary NMRs or levels of smoking.Variation in 3HC glucuronidation activity, including these caused by UGT2B17 gene deletions, did not significantly alter NMR and is therefore unlikely to affect the clinical utility of NMR in smoking behavior and cessation studies. This study demonstrates that NMR is not altered by differences in the rate of 3HC glucuronidation, providing further support that NMR is a reliable indicator of CYP2A6 mediated nicotine metabolism.