Cannabis Use Among Adults in Cigarette Smoking Cessation Treatment in Ontario, Canada: Prevalence and Association With Tobacco Cessation Outcome, 2015-2021.

Objectives. To examine cannabis use prevalence and its association with tobacco cessation among adults enrolled in cigarette smoking cessation treatment before and after Canada legalized recreational cannabis in October 2018. Methods. The sample comprised 83 206 adults enrolled in primary care-based cigarette smoking cessation treatment between 2015 and 2021 in Ontario, Canada. Past-30-day cannabis use was self-reported at enrollment and cigarette smoking abstinence at 6-month follow-up. Results. Past-30-day prevalence of cannabis use increased from 20.2% in 2015 to 37.7% in 2021. The prevalence increased linearly both before and after legalization. Cannabis and tobacco co-use was associated with lower odds of self-reported cigarette smoking abstinence at 6-month follow-up than tobacco use only (24.4% vs 29.3%; odds ratio [OR] = 0.78; 95% confidence interval [CI] = 0.75, 0.81). This association was attenuated after adjustment for covariates (OR = 0.93; 95% CI = 0.89, 0.97) and weakened slightly over time. Conclusions. Cannabis use prevalence almost doubled from 2015 to 2021 among primary care patients in Ontario seeking treatment to quit cigarettes and was associated with poorer quit outcomes. Further research into the impact of cannabis policy on cannabis and tobacco co-use is warranted to mitigate harm. (Am J Public Health. 2024;114(1):98-107. https://doi.org/10.2105/AJPH.2023.307445).

Concurrent E-cigarette Use While Enrolled in a Smoking Cessation Program: Associations Between Frequency of Use, Motives for Use, and Smoking Cessation.

INTRODUCTION: Trial evidence suggests that e-cigarettes may aid in quitting smoking, while observational studies have found conflicting results. However, many observational studies have not adjusted for important differences between e-cigarette users and non-users. AIMS AND METHODS: We aimed to determine the association between e-cigarette use frequency and motivation to use e-cigarettes to quit smoking, and smoking cessation using data from Canada's largest smoking cessation program. Participants who completed a baseline assessment and 6-month follow-up questionnaire were divided post hoc into four groups based on their self-reported e-cigarette use during the 30 days before baseline: (1) non-users; (2) users of e-cigarettes not containing nicotine; (3) occasional users; and (4) frequent users. Occasional and frequent users were further divided into two groups based on whether they reported using e-cigarettes to quit smoking. Abstinence at 6-month follow-up (7-day point prevalence abstinence) was compared among groups. RESULTS: Adjusted quit probabilities were significantly higher (both p < .001) for frequent baseline e-cigarette users (31.6%; 95% CI = 29.3%, 33.8%) than for non-users (25.8%; 25.3% and 26.3%) or occasional users (24.2%; 22.5% and 26.0%). Unadjusted proportions favored non-users over occasional users (p < .001), but this was not significant after adjustment (p = .06). People using e-cigarettes to quit smoking were not likelier than other users to be successful, but were likelier to report frequent e-cigarette use during follow-up. CONCLUSIONS: Frequent baseline e-cigarette use predicted successful smoking cessation, compared to occasional and non-users. Use of e-cigarettes to quit did not predict smoking cessation but was associated with continued use during follow-up, perhaps due in part to planned transitions to e-cigarettes. IMPLICATIONS: Prior observational studies investigating e-cigarette use for smoking cessation have found that occasional users have poorer outcomes than either frequent or non-users. Consistent with these studies, occasional users in our data also had poorer outcomes. However, after adjustment for variables associated with cessation success, we found that cessation probabilities did not differ between occasional and non-users. These findings are consistent with trial data showing the benefit of e-cigarette use among people trying to quit smoking. Results of this study suggest that differences between trials and previous observational studies may be because of unaddressed confounding in the latter.

Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review.

BACKGROUND: Adhering to varenicline has been shown to significantly improve the chances of successfully quitting smoking, with studies indicating a twofold increase in 6-month quit rates. However, despite its potential benefits, many individuals struggle with maintaining good adherence to varenicline; thus there is a need to develop scalable strategies to help people adhere. As a first step to inform the development of an intervention to improve adherence to varenicline, we conducted a rapid literature review to identify: 1) modifiable barriers and facilitators to varenicline adherence, and 2) behaviour change techniques associated with increased adherence to varenicline. METHODS: We searched MEDLINE, Embase, APA PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials for relevant studies published between 2006 and 2022. Search terms included "varenicline," "smoking cessation," and "adherence," and their respective subject headings and synonyms. We screened and included studies reporting modifiable determinants of adherence to varenicline and then assessed quality, extracted modifiable determinants and mapped them to the Theoretical Domains Framework version 2 and the Behaviour Change Technique Taxonomy version 1. RESULTS: A total of 1,221 titles were identified through the database searches; 61 met the eligibility criteria. Most of the studies were randomized controlled trials and predominantly focused on barriers to varenicline. Only nine studies explicitly mentioned behaviour change techniques used to help varenicline adherence. Eight domains were identified as barriers to varenicline adherence (behavioural regulation, memory, goals, intentions, beliefs about capabilities, beliefs about consequences, optimism/pessimism, and environmental context) and five as facilitators (knowledge, behavioural regulation, beliefs about capabilities, social influences, and environmental context). CONCLUSIONS: This study identifies barriers and facilitators that should be addressed when developing a complex adherence intervention tailored to patients' needs based on modifiable determinants of medication adherence, some of which are under- used by existing adherence interventions. The findings from this review will inform the design of a theory-based healthbot planned to improve varenicline adherence in people undergoing smoking cessation treatment. SYSTEMATIC REVIEW REGISTRATION: This study was registered with PROSPERO (# CRD42022321838).

Effectiveness of Bupropion and Varenicline for Smokers With Baseline Depressive Symptoms.

INTRODUCTION: Smokers with concurrent depression are less likely to achieve abstinence, even with pharmacotherapy. The purpose of this secondary data analysis was to evaluate if the presence of any depressive symptoms at baseline alters the effectiveness of bupropion and varenicline for smoking cessation. AIMS AND METHODS: Eligible participants were enrolled via the internet and randomized 1:1 to receive a 12-week supply of either bupropion (n = 465) or varenicline (n = 499). Depressive symptoms were assessed using the Patient Health Questionnaire (PHQ-2). Follow-up surveys were conducted at weeks 4, 8, 12, 26, and 52 to assess self-reported quit. The primary outcome was 7-day point prevalence abstinence at 12 weeks follow-up (end-of-treatment). RESULTS: Participants who endorsed any depressive symptoms (PHQ-2 > 0; n = 280) were less likely to be quit at end-of-treatment compared to participants who did not endorse any symptoms (PHQ-2 = 0; n = 684) (OR = 0.56, 95% CI: 0.38 to 0.8, p = .003). Within the varenicline group, quit outcomes did not differ between those with and without depressive symptoms (21.3% vs. 26.9%, respectively). Within the bupropion group, however, those with symptoms had a significantly reduced quit rate compared to those without symptoms (7.0% vs. 17.3%, respectively). CONCLUSIONS: The presence of even one symptom of depression at the start of a quit attempt may adversely affect quit outcomes. Patients should be assessed for depressive symptoms when planning to quit smoking as it may inform the approach to treatment. However, future studies are needed to confirm these findings. IMPLICATIONS: Findings from the current study illustrate the importance of evaluating baseline sub-clinical depressive symptoms before a quit attempt using first-line pharmacotherapies. This secondary analysis of a large-scale randomized trial suggests that bupropion may be less effective for those with baseline depressive symptoms while varenicline may be equally effective for those with and without depressive symptoms.

Association Between Smoking Cessation Treatment and Healthcare Costs in a Single-Payer Public Healthcare System.

INTRODUCTION: There has been little investigation of whether the clinical effectiveness of smoking cessation treatments translates into differences in healthcare costs, using real-world cost data, to determine whether anticipated benefits of smoking cessation treatment are being realized. AIMS AND METHODS: We sought to determine the association between smoking cessation treatment and healthcare costs using linked administrative healthcare data. In total, 4752 patients who accessed a smoking cessation program in Ontario, Canada between July 2011 and December 2012 (treatment cohort) were each matched to a smoker who did not access these services (control cohort). The primary outcome was total healthcare costs in Canadian dollars, and secondary outcomes were sector-specific costs, from one year prior to the index date until December 31, 2017, or death. Costs were partitioned into four phases: pretreatment, treatment, posttreatment, and end-of-life for those who died. RESULTS: Among females, total healthcare costs were similar between cohorts in pretreatment and posttreatment phases, but higher for the treatment cohort during the treatment phase ($4,554 vs. $3,237, p < .001). Among males, total healthcare costs were higher in the treatment cohort during pretreatment ($3,911 vs. $2,784, p < .001), treatment ($4,533 vs. $3,105, p < .001) and posttreatment ($5,065 vs. $3,922, p = .001) phases. End-of-life costs did not differ. Healthcare sector-specific costs followed a similar pattern. CONCLUSIONS: Five-year healthcare costs were similar between females who participated in a treatment program versus those that did not, with a transient increase during the treatment phase only. Among males, treatment was associated with persistently higher healthcare costs. Further study is needed to address the implications with respect to long-term costs. IMPLICATIONS: The clinical effectiveness of pharmacological and behavioral smoking cessation treatments is well established, but whether such treatments are associated with healthcare costs, using real-world data, has received limited attention. Our findings suggest that the use of a smoking cessation treatment offered by their health system is associated with persistent higher healthcare costs among males but a transient increase among females. Given increasing access to evidence-based smoking cessation treatments is an important component in national tobacco control strategies, these data highlight the need for further exploration of the relations between smoking cessation treatment engagement and healthcare costs.

Primary care-based smoking cessation treatment and subsequent healthcare service utilisation: a matched cohort study of smokers using linked administrative healthcare data.

BACKGROUND: No research has assessed the individual-level impact of smoking cessation treatment delivered within a general primary care patient population on multiple forms of subsequent healthcare service use. OBJECTIVE: We aimed to compare the rate of outpatient visits, emergency department (ED) visits and hospitalisations during a 5-year follow-up period among smokers who had and had not accessed a smoking cessation treatment programme. METHODS: The study was a retrospective matched cohort study using linked demographic and administrative healthcare databases in Ontario, Canada. 9951 patients who accessed smoking cessation services between July 2011 and December 2012 were matched to a smoker who did not access services, obtained from the Canadian Community Health Survey, using a combination of hard matching and propensity score matching. Outcomes were rates of healthcare service use from index date (programme enrolment or survey response) to March 2017. RESULTS: After controlling for potential confounders, patients in the overall treatment cohort had modestly greater rates of the outcomes: outpatient visits (rate ratio (RR) 1.10, 95% CI: 1.06 to 1.14), ED visits (RR 1.08, 95% CI: 1.03 to 1.13) and hospitalisations (RR 1.09, 95% CI: 1.02 to 1.18). Effect modification of the association between smoking cessation treatment and healthcare service use by prevalent comorbidity was found for outpatient visits (p=0.006), and hospitalisations (p=0.050), but not ED visits. CONCLUSIONS: Patients who enrolled in smoking cessation treatment offered through primary care clinics in Ontario displayed a modest but significantly greater rate of outpatient visits, ED visits and hospitalisations over a 5-year follow-up period.

Outcomes Among People With Schizophrenia Participating in General-Population Smoking Cessation Treatment: An Observational Study.

OBJECTIVE: People with schizophrenia are much more likely than others to smoke tobacco, raising risks of disease and premature mortality. These individuals are also less likely to quit successfully after treatment, but the few existing clinical and observational studies have been limited by small sample sizes, and have generally considered specialized treatment approaches. In this analysis, we examine outcomes, service use, and potential explanatory variables in a large sample of people with schizophrenia treated in a general-population cessation program. METHOD: Our sample comprised 3,011 people with schizophrenia and 77,790 controls receiving free nicotine replacement therapy through 400 clinics and health centres. We analysed self-reported 7-day abstinence or reduction at 6-month follow-up, as well as the number of visits attended and self-reported difficulties in quitting. We adjusted for demographic, socioeconomic, and health variables, and used multiple imputation to address missing data. RESULTS: Abstinence was achieved by 16.2% (95% confidence interval [CI], 14.5% to 17.8%) of people with schizophrenia and 26.4% (95% CI, 26.0% to 26.7%) of others (absolute difference = 10.2%; 95% CI, 8.5% to 11.9%; P < 0.001). After adjustment, this difference was reduced to 7.3% (95% CI, 5.4% to 9.3%; P < 0.001). Reduction in use was reported by 11.8% (95% CI, 10.3% to 13.3%) and 12.5% (95% CI, 12.2% to 12.8%), respectively; this difference was nonsignificant after adjustment. People with schizophrenia attended more clinic visits (incidence rate ratio [IRR] = 1.15, 95% CI = 1.12% to 1.18%, P < 0.001) and reported more difficulties related to "being around other smokers" (odds ratio [OR] = 1.28; 95% CI, 1.11% to 1.47%; P = 0.001). CONCLUSION: There is abundant demand for tobacco cessation treatment in this population. Outcomes were substantially poorer for people with schizophrenia, and this difference was not explained by covariates. Cessation remained much better than for unaided quit attempts, however, and engagement was high, demonstrating that people with schizophrenia benefit from nonspecialized pharmacological treatment programs.

Effects of COVID-19-Related Disruptions on Service Use in a Large Smoking Cessation Program.

INTRODUCTION: The COVID-19 pandemic caused a rapid shift to virtual care, with largely unknown consequences for accessibility. The purpose of this study is to examine pandemic-related changes in use of care for smoking cessation. AIMS AND METHODS: We conducted a secondary analysis 65 565 enrollments in a large smoking cessation program in Ontario, Canada. We used piecewise mixed-effects regression to examine how weeks nicotine replacement therapy (NRT) received, as well as counseling provided and visits attended, varied with date of enrollment over three time periods: more than 6 months before the pandemic began; the 6 months before the pandemic; and the pandemic period itself. We then examined changes in the associations between use of care and participant characteristics by fitting a model including a set of interactions between time and other variables. Based on an omnibus test of these interactions, we then tested individual terms, using the Holm method to control the family-wise error rate. RESULTS: From the start of the pandemic in March 2020, the total weeks of NRT provided rose significantly and then declined, while the amount of counseling fell. Associations between NRT use and participant characteristics changed significantly after the pandemic onset. Individual models showed that people with lower income, living in areas of higher marginalization, unable to work, and reporting higher levels of depressive symptoms all received NRT for a longer time during the pandemic period. CONCLUSIONS: The pandemic led to small but significant changes in the amount of services used per enrollment. The transition to remote care appears to have reduced the effects of socioeconomic and health barriers. IMPLICATIONS: The amount of care used by participants in tobacco cessation treatment is known to be associated with health and sociodemographic characteristics. Most of these associations did not change markedly following the pandemic-related switch to virtual care in 2020; however, the effects of some economic and health barriers seem to have lessened, perhaps because of a likely reduction in transport and time requirements of treatment.

Treatment use patterns in a large extended-treatment tobacco cessation program: predictors and cost implications.

BACKGROUND: Tobacco dependence follows a chronic and relapsing course, but most treatment programmes are short. Extended care has been shown to improve outcomes. Examining use patterns for longer term programmes can quantify resource requirements and identify opportunities for improving retention. METHODS: We analyse 38 094 primary care treatment episodes from a multisite smoking cessation programme in Ontario, Canada that provides free nicotine replacement therapy (NRT) and counselling. We calculate distributional measures of weeks of NRT used, clinical visits attended and total length of care. We then divide treatment courses into four exclusive categories and fit a multinomial logistic regression model to measure associations with participant characteristics, using multiple imputation to address missing data. RESULTS: Time in treatment (median=50 days), visits (median=3) and weeks NRT used (median=8) were well below the maximum available. Of all programme enrolments, 28.8% (95% CI=28.3% to 29.3%) were single contacts, 31.3% (30.8% to 31.8%) lasted <12 weeks, 19.2% (18.8% to 19.6%) were ≥12 weeks with an 8-week interruption and 20.7% (20.3%-21.1%) were ≥12 weeks without interruptions. Care use was most strongly associated with participant age and whether the nicotine patch was dispensed at the first visit. CONCLUSION: Treatment use results imply that the marginal costs of extending treatment programmes are relatively low. The prevalence of single contacts supports additional engagement efforts at the initial visit, while interruptions in care highlight the ability of longer term care to address relapse. Results show that use of the nicotine patch is associated with retention in care, and that improving engagement of younger patients should be a priority.

The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial.

BACKGROUND: People who smoke have other risk factors for chronic diseases, such as low levels of physical activity and poor diet. Clinical decision support systems (CDSSs) might help health care practitioners integrate interventions for diet and physical activity into their smoking cessation programming but could worsen quit rates. OBJECTIVE: The aims of this study are to assess the effects of the addition of a CDSS for physical activity and diet on smoking cessation outcomes and to assess the implementation of the study. METHODS: We conducted a pragmatic hybrid type I effectiveness-implementation trial with 232 team-based primary care practices in Ontario, Canada, from November 2019 to May 2021. We used a 2-arm randomized controlled trial comparing a CDSS addressing physical activity and diet to treatment as usual and used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to measure implementation outcomes. The primary outcome was self-reported 7-day tobacco abstinence at 6 months. RESULTS: We enrolled 5331 participants in the study. Of these, 2732 (51.2%) were randomized to the intervention group and 2599 (48.8%) to the control group. At the 6-month follow-up, 29.7% (634/2137) of respondents in the intervention arm and 27.3% (552/2020) in the control arm reported abstinence from tobacco. After multiple imputation, the absolute group difference was 2.1% (95% CI -0.5 to 4.6; F1,1000.42=2.43; P=.12). Mean exercise minutes changed from 32 (SD 44.7) to 110 (SD 196.1) in the intervention arm and from 32 (SD 45.1) to 113 (SD 195.1) in the control arm (group effect: B=-3.7 minutes; 95% CI -17.8 to 10.4; P=.61). Servings of fruit and vegetables changed from 2.64 servings to 2.42 servings in the intervention group and from 2.52 servings to 2.45 servings in the control group (incidence rate ratio for intervention group=0.98; 95% CI 0.93-1.02; P=.35). CONCLUSIONS: A CDSS for physical activity and diet may be added to a smoking cessation program without affecting the outcomes. Further research is needed to improve the impact of integrated health promotion interventions in primary care smoking cessation programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223336 https://www.clinicaltrials.gov/ct2/show/NCT04223336. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19157.

The Effectiveness of Nicotine Replacement Therapy in Light Versus Heavier Smokers.

INTRODUCTION: The prevalence of light smoking has increased in North America; however, research on the effectiveness of current treatments in this subpopulation of smokers is limited. We compared quit outcomes between light (1-10 cigarettes per day [CPD]) versus heavier smokers (>10 CPD) enrolled in a treatment program at their primary care clinic. AIMS AND METHODS: This secondary analysis analyzed 45 087 participants (light smokers [n = 9861]; heavier smokers [n = 35 226]) enrolled in a smoking cessation program between April 2016 and March 2020. The program offered cost-free nicotine replacement therapy (NRT) plus in-person counseling. Type, dose, and duration of NRT treatment were personalized. Data were collected at baseline, and at 6 months following enrollment to assess 7-day point prevalence abstinence (PPA), the primary outcome variable of interest. Logistic regression models were used for analyses. RESULTS: Seven-day PPA at 6 months was significantly higher among light smokers (30.6%) than heavier smokers (26.0%; odds ratio = 1.25, 95% confidence interval = 1.18-1.33, p < .001). Heavier smokers were prescribed more weeks of NRT than light smokers (B = 0.82, 95% confidence interval = 0.64-1.0, p < .001). The association between smoking cessation and daily NRT dose did not differ between groups (p = .98). However, a stronger positive relationship between the number of clinic visits attended and 7-day PPA was found among heavier smokers in comparison to light smokers (p < .001). All findings remained significant after adjusting for baseline variables. CONCLUSIONS: There is a paucity of scientific literature on the effectiveness of NRT for light smokers. Our findings suggest that individualized doses of NRT may be helpful in these subpopulations, and highlight the different treatment needs of light smokers. IMPLICATIONS: Current clinical guidelines do not provide formal recommendations for light smokers who want to quit smoking. Similar to heavy smokers, light smokers are at substantial risk for many adverse health problems. As such, it is important to understand what treatment options are effective in assisting light smokers to quit smoking. Findings from this study support the use of personalized treatment for all smokers who are interested in quitting smoking, including light smokers.

Seasonal Variation in Demand for Smoking Cessation Treatment and Clinical Outcomes.

INTRODUCTION: Smoking behaviour shows seasonal variation, with cigarette consumption and youth smoking onset highest in summer and smoking-related web searches and sales of nicotine replacement products highest in winter. Variation in demand for clinical care and in outcomes has not been explored. AIMS AND METHODS: We measure seasonal variation in enrolments, total clinical visits, visits per enrolment, and treatment outcome (7-day abstinence at 6-month follow-up) from 2015 to 2018 in a large (n = 85 869) clinical cohort from 454 clinics across Ontario, Canada. We model seasonality using harmonic logistic and negative binomial regression. For individual-level outcomes, we adjust for variables, selected a priori, known to be associated with treatment use or outcomes. Data are nearly complete for 3 outcomes, but 6m abstinence is missing for 45% of participants. We use multiple imputation to adjust for missing data. RESULTS: All four outcomes showed significant seasonal variation (all p <.001). Total enrolments and visits were 20%-25% higher in January-April than in June-September. Visits per enrolment varied slightly, with lowest levels from May-July. Abstinence at 6 months was lowest among individuals enrolled from February-May and highest for those enrolled from July-November, with an absolute peak-trough difference of 4.3% (95% CI = 3.2% to 5.5%). CONCLUSIONS: There is meaningful seasonal variation in demand for, and outcomes of, smoking cessation treatment. Climate and weather may be indirectly responsible. Seasonal differences underscore the general importance of contextual factors in smoking cessation, may be useful in program promotion, and may explain some variability in outcomes in evaluation and research. IMPLICATIONS: Demand for tobacco cessation treatment and clinical outcomes vary seasonally. This underscores the importance of context in substance-related problems, and implies that some variability in research and evaluation results may be due to the time of year data were collected. Promotion efforts might usefully consider seasonal effects to smooth out demand and possibly improve outcomes.

A Comparison of Quit Outcomes for Men and Women in a Smoking Cessation Program Offering Personalized Nicotine Replacement Therapy and Counseling in Primary Care Clinics.

INTRODUCTION: Women may have greater difficulty achieving long-term abstinence following a quit attempt compared to men. We sought to determine whether there were differences in treatment characteristics or outcome between female and male primary care patients enrolled in a smoking cessation program providing personalized nicotine replacement therapy (NRT) with counseling support. AIMS AND METHODS: The sample included 27 601 Ontarians (53% female, 47% male) who enrolled in the Smoking Treatment for Ontario Patients program between 2016 and 2018. Dose, type, and duration of NRT supplied were personalized to need. Thirty-day point prevalence tobacco smoking abstinence was self-reported via online or telephone survey at 6 months after enrollment. RESULTS: Both female and male participants received a median of 8 weeks of NRT. Types of NRT received were similar, with 80% of both female and male participants receiving patch and short-acting NRT. The total cumulative dose was somewhat higher for men (1373 mg vs. 1265 mg, p < .001); but when calculated as dose per day, per cigarette smoked at baseline, the dose was slightly higher among women (1.6 mg vs. 1.5 mg, p < .001). Quit rates at 6 months were lower for women versus men (24% vs. 27%; adjusted OR = 0.84 [95% CI = 0.78 to 0.90], p < .001). There were no significant interactions between gender and dose, type, or duration of NRT supplied. CONCLUSIONS: Women were slightly less likely to quit than men, despite receiving similar treatment. There was no evidence that women benefitted more or less from variations in dose, type, or duration of NRT supplied. IMPLICATIONS: Women who received personalized NRT with counseling support in a primary care setting had lower quit success than men. Although the absolute difference in quit outcome was small, the public health impact may be large given the burden of disease associated with continued smoking. NRT supplied was similar for women and men, and there was no evidence upon which to suggest tailoring the dose, duration, or type, based on gender alone. Further research to identify the underlying biological and social factors responsible for reduced quit success will help identify ways to optimize treatment for women.

Safety and Efficacy of Varenicline for Smoking Cessation in Alcohol-Dependent Smokers in Concurrent Treatment for Alcohol Use Disorder: A Pilot, Randomized Placebo-Controlled Trial.

BACKGROUND: Smoking prevalence among those with alcohol dependence is much higher than the general population. Despite this, cessation treatment in those with concurrent alcohol dependence is seldom undertaken. We conducted a randomized, placebo-controlled, double-blind pilot study, whereby patients enrolled at an addiction treatment facility in downtown Toronto, Canada, were recruited and assigned to placebo or varenicline treatment for 12 weeks. We hypothesized that varenicline would be a safe and efficacious treatment for tobacco dependence in this population. METHODS: Daily dependent smokers in treatment for alcohol dependence and interested in participating in the study were first screened over the phone and then assessed in-person. If eligible, they were randomly assigned to placebo or varenicline in a double-blind fashion. They attended weekly appointments for smoking cessation counseling and completed daily diaries for the full 12 weeks of treatment. RESULTS: Thirty-one subjects were randomized to either varenicline (n = 16) or placebo treatment (n = 15). Participants were predominantly male (73.3%) with a mean age of 44.6 (23-66). Only one subject in the placebo group was quit by end of treatment (7-day point prevalence abstinence), compared with 7 in the varenicline group (χ(1) = 5.56, P = 0.037). Both groups had a significant decline in cigarettes per day (CPD) by end of treatment (varenicline = 22.1 ± 13.3 to 2.0 ± 3.0 CPD, t(10) = 4.45, P = 0.001; placebo: 14.9 ± 4.4 to 5.3 ± 6.3 CPD, t(13) = 3.61, P = 0.003). CONCLUSIONS: The results from this pilot study indicate that varenicline is a safe and effective treatment for tobacco dependence in a sample of alcohol-dependent smokers undergoing concurrent treatment for alcohol use disorder.

Identifying contexts and mechanisms in multiple behavior change interventions affecting smoking cessation success: a rapid realist review.

BACKGROUND: Smoking continues to be a leading cause of preventable chronic disease-related morbidity and mortality, excess healthcare expenditure, and lost work productivity. Tobacco users are disproportionately more likely to be engaging in other modifiable risk behaviours such as excess alcohol consumption, physical inactivity, and poor diet. While hundreds of interventions addressing the clustering of smoking and other modifiable risk behaviours have been conducted worldwide, there is insufficient information available about the context and mechanisms in these interventions that promote successful smoking cessation. The aim of this rapid realist review was to identify possible contexts and mechanisms used in multiple health behaviour change interventions (targeting tobacco and two or more additional risk behaviours) that are associated with improving smoking cessation outcome. METHODS: This realist review method incorporated the following steps: (1) clarifying the scope, (2) searching for relevant evidence, (3) relevance confirmation, data extraction, and quality assessment, (4) data analysis and synthesis. RESULTS: Of the 20,423 articles screened, 138 articles were included in this realist review. Following Michie et al.'s behavior change model (the COM-B model), capability, opportunity, and motivation were used to identify the mechanisms of behaviour change. Universally, increasing opportunities (i.e. factors that lie outside the individual that prompt the behaviour or make it possible) for participants to engage in healthy behaviours was associated with smoking cessation success. However, increasing participant's capability or motivation to make a behaviour change was only successful within certain contexts. CONCLUSION: In order to address multiple health behaviours and assist individuals in quitting smoking, public health promotion interventions need to shift away from 'individualistic epidemiology' and invest resources into modifying factors that are external from the individual (i.e. creating a supportive environment). TRIAL REGISTRATION: PROSPERO registration number: CRD42017064430.

The Value of Biosamples in Smoking Cessation Trials: A Review of Genetic, Metabolomic, and Epigenetic Findings.

Introduction: Human genetic research has succeeded in definitively identifying multiple genetic variants associated with risk for nicotine dependence and heavy smoking. To build on these advances, and to aid in reducing the prevalence of smoking and its consequent health harms, the next frontier is to identify genetic predictors of successful smoking cessation and also of the efficacy of smoking cessation treatments ("pharmacogenomics"). More broadly, additional biomarkers that can be quantified from biosamples also promise to aid "Precision Medicine" and the personalization of treatment, both pharmacological and behavioral. Aims and Methods: To motivate ongoing and future efforts, here we review several compelling genetic and biomarker findings related to smoking cessation and treatment. Results: These Key results involve genetic variants in the nicotinic receptor subunit gene CHRNA5, variants in the nicotine metabolism gene CYP2A6, and the nicotine metabolite ratio. We also summarize reports of epigenetic changes related to smoking behavior. Conclusions: The results to date demonstrate the value and utility of data generated from biosamples in clinical treatment trial settings. This article cross-references a companion paper in this issue that provides practical guidance on how to incorporate biosample collection into a planned clinical trial and discusses avenues for harmonizing data and fostering consortium-based, collaborative research on the pharmacogenomics of smoking cessation. Implications: Evidence is emerging that certain genotypes and biomarkers are associated with smoking cessation success and efficacy of smoking cessation treatments. We review key findings that open potential avenues for personalizing smoking cessation treatment according to an individual's genetic or metabolic profile. These results provide important incentive for smoking cessation researchers to collect biosamples and perform genotyping in research studies and clinical trials.

Leveraging Genomic Data in Smoking Cessation Trials in the Era of Precision Medicine: Why and How.

Implications: This article outlines a framework for the consistent integration of biological data/samples into smoking cessation pharmacotherapy trials, aligned with the objectives of the recently unveiled Precision Medicine Initiative. Our goal is to encourage and provide support for treatment researchers to consider biosample collection and genotyping their existing samples as well as integrating genetic analyses into their study design in order to realize precision medicine in treatment of nicotine dependence.

Public health impact of a novel smoking cessation outreach program in Ontario, Canada.

BACKGROUND: Provision of evidence-based smoking cessation treatment may contribute to health disparities if barriers to treatment are greater for more disadvantaged groups. We describe and evaluate the public health impact of a novel outreach program to improve access to smoking cessation treatment in Ontario, Canada. METHODS: We partnered with Public Health Units (PHUs) located across the province to deliver single-session workshops providing standardized evidence-based content and 10 weeks (2007-2008) or 5 weeks (2008-2016) of nicotine replacement therapy (NRT). Participants completed a baseline assessment and were followed up by phone or e-mail at 6 months. We used the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework to evaluate the public health impact of the program from 2007 to 2016. Given the iterative design and changes in implementation over time, data is presented annually or bi-annually. RESULTS: There were 26,122 enrollments from 2007 to 2016. Between 31 and 442 workshops were held annually. The annual reach was estimated to be 0.1-0.3% of eligible smokers in Ontario. Participants were older, smoked more heavily, had a lower household income, were more likely to be female and be diagnosed with a mood or anxiety disorder, and less likely to have a postsecondary degree compared to average Ontario smokers eligible for participation. The intervention was effective; at 6-month follow-up 22-33% of respondents reported abstinence from smoking. Adoption by PHUs was 81% by the second year of operation and remained high (72-97%) thereafter, with the exception of 2009-2010 (33-56%) when the program was temporarily unavailable to PHUs due to lack of funding. Implementation at the organizational level was not tracked; however, at the individual level, approximately half of participants used most or all of the NRT received. On average, maintenance of the program was high, with PHUs conducting workshops for 7 of the 10 years (2007-2016) and 4 of the 5 most recent years (2012-2016). CONCLUSIONS: The smoking cessation program had a high rate of adoption and maintenance, reached smokers over a large geographic area, including individuals more likely to experience disparities, and helped them make successful quit attempts. This novel model can be adopted in other jurisdictions with limited resources.

Concurrent E-Cigarette Use During Tobacco Dependence Treatment in Primary Care Settings: Association With Smoking Cessation at Three and Six Months.

INTRODUCTION: Electronic cigarettes (e-cigarettes) are being used as cessation aids by many smokers despite a lack of empirical evidence regarding their safety and efficacy. We analyzed the association of e-cigarette use and smoking abstinence in a population of smokers accessing standard smoking cessation treatment (nicotine replacement therapy [NRT] plus behavioral counseling) through primary care clinics in Ontario, Canada. METHODS: Participants were recruited through 187 primary care clinics across Ontario, Canada and were eligible for up to 26 weeks of brief behavioral counseling and individualized dosing of NRT at no cost. Adjusted logistic regression models were used to examine the association between concurrent e-cigarette use and smoking abstinence at 3- and 6-month follow-ups. RESULTS: Of the 6526 participants who completed a 3-month follow-up, 18.1% reported using an e-cigarette while in treatment. The majority of e-cigarette users (78.2%) reported using an e-cigarette for smoking cessation. At 3-month follow-up, e-cigarette use was negatively associated with abstinence after controlling for confounders (adjusted odds ratio [AOR] = 0.706, p < .001, 95% confidence interval [CI] = 0.607-0.820). E-cigarette use was also negatively associated with abstinence at 6-month follow-up (AOR = 0.502, p < .001, 95% CI = 0.393-0.640). CONCLUSION: E-cigarette use was negatively associated with successful quitting in this large community sample of smokers accessing standard evidence-based smoking cessation treatment through primary care clinics, even after adjusting for covariates such as severity of tobacco dependence, gender, and age. The findings suggest that concurrent use of e-cigarettes with NRT may harm cessation attempts. IMPLICATIONS: This study confirms previous findings from observational studies regarding the negative association between e-cigarette use and smoking cessation, but in a large cohort of smokers enrolled in an evidence-based treatment program. The implications of these findings are that concurrent use of e-cigarettes during a quit attempt utilizing cost-free evidence-based treatment (NRT plus behavioral counseling) does not confer any added benefit and may hamper successful quitting.