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Efficacy of smoking cessation with varenicline plus counselling for e-cigarettes users (VAREVAPE): A protocol for a randomized controlled trial.

ABSTRACT: Tobacco smoking is a global pandemic that poses substantial health burdens and costs. With nearly six million deaths annually, smoking is the single most important cause of avoidable premature mortality in the world, mainly from lung cancer, coronary heart disease, chronic obstructive pulmonary disease and stroke. Smoking is a very difficult addiction to break, even for those with a strong desire to quit. Electronic cigarettes are an attractive long-term alternative source of nicotine to conventional cigarettes because of their many similarities with smoking. Electronic cigarette users report buying them to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, to quit, and to continue having a 'smoking' experience, but with reduced health risks. Actually, there aren't antismoking treatments for people who smoke only electronic cigarette (single users) or electronic cigarette and classic cigarette (dual users). There isn't any specific information on the efficacy and safety of new pharmacological support for electronic cigarette users. We propose that smoking cessation with varenicline plus counselling delivered to electronic cigarette users could be associated with similar smoking abstinence rates compared to the results obtained in the general population. Herein, we describe the methodology of a double-blind, placebo-controlled, randomized clinical trial, of 24 weeks duration, that examines the efficacy of varenicline (1?mg BID - for 12 weeks) plus counselling compared to matched placebo (1?mg BID - for 12 weeks) plus counselling.

SUBMITTER: Caponnetto P

PROVIDER: S-EPMC6667779 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Efficacy of smoking cessation with varenicline plus counselling for e-cigarettes users (VAREVAPE): A protocol for a randomized controlled trial.

Caponnetto Pasquale P Maglia Marilena M Polosa Riccardo R

Contemporary clinical trials communications 20190719

Tobacco smoking is a global pandemic that poses substantial health burdens and costs. With nearly six million deaths annually, smoking is the single most important cause of avoidable premature mortality in the world, mainly from lung cancer, coronary heart disease, chronic obstructive pulmonary disease and stroke. Smoking is a very difficult addiction to break, even for those with a strong desire to quit. Electronic cigarettes are an attractive long-term alternative source of nicotine to convent ...[more]

PMID: 31388599

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Project description:BackgroundAlthough many smokers use electronic cigarettes (e-cigarettes) to quit smoking, most continue to smoke while vaping. This dual use might delay cessation and increase toxicant exposure. We aimed to test the efficacy of a self-help intervention designed to help dual users to quit smoking.MethodsIn this three-arm randomised controlled trial we recruited individuals in the USA using Facebook and multimedia advertisements. Included participants were 18 years or older, smoked at least weekly in the preceding year, and vaped at least weekly in the preceding month. We used computer generated randomisation with balanced-permuted blocks (block size 10, with 2-4-4 ratio) to allocate participants to assessment only (ASSESS group), generic smoking cessation self-help booklets (GENERIC group), or booklets targeting dual users (eTARGET group). Individuals in the generic or targeted intervention groups received monthly cessation materials for 18 months, with assessments every 3 months for 24 months. The main outcome was self-reported 7-day point-prevalence smoking abstinence at each assessment point. All randomly allocated participants were included in primary analyses using generalised estimating equations for each of 20 datasets created by multiple imputation. Analysis of the χ2s produced an F test. The trial is registered with ClinicalTrials.gov, NCT02416011, and is now closed.FindingsBetween July 12, 2016, and June 30, 2017, we randomly assigned 2896 dual users (575 to assessment, 1154 to generic intervention, and 1167 to targeted self-help). 7-day point-prevalence smoking abstinence increased from 14% at 3 months to 42% at 24 months (F7,541·7=67·1, p<0·0001) in the overall sample. Targeted self-help resulted in higher smoking abstinence than did assessment alone throughout the treatment period (F1,973·8=10·20, p=0·0014 [α=0·017]). The generic intervention group had abstinence rates between those of the assessment and targeted groups, but did not significantly differ from either when adjusted for multiple comparisons (GENERIC vs eTARGET F1,1102·5=1·79, p=0·18 [α=0·05]; GENERIC vs ASSESS F1,676·7=4·29, p=0·039 [α=0·025]). Differences between study groups attenuated after the interventions ended.InterpretationA targeted self-help intervention with high potential for dissemination could be efficacious in promoting smoking cessation among dual users of combustible cigarettes and e-cigarettes.FundingNational Institute on Drug Abuse, National Cancer Institute.

Project description:IntroductionWomen have lower rates of quitting than men with both bupropion and nicotine replacement. It is unknown whether varenicline demonstrates differential efficacy for men and women. The purpose of this study was to conduct the first comprehensive meta-analysis of clinical trial data examining sex differences in the efficacy of varenicline for smoking cessation.MethodsSearching MEDLINE, EMBASE, and PsychINFO, 17 of 43 clinical trials of varenicline for smoking cessation published through December 31, 2014 were low-bias randomized double-blind placebo-controlled trials. Data (n = 6710 smokers, 34% female, n = 16 studies, 96% of available data) was analyzed with Metafor program in R. Outcome endpoints were 7-day point-prevalence (PP) and continuous-abstinence (CA) at week 12 (end of treatment), week 24 (6-month follow-up), and week 52 (12-month follow-up).ResultsUsing placebo, women were less likely than men to quit (PP-12, CA-24; P < .05 for sex). Using varenicline, similar rates of abstinence for men and women were demonstrated for all six outcomes (eg, PP-12 abstinence rates were 53% in both women and men). Varenicline versus placebo outcomes demonstrated that varenicline was more effective for women for short and intermediate outcomes (PP-12, CA-12, CA-24; P < .05 sex × medication interaction). For end-of-treatment PP, varenicline was 46% more effective for women. For continuous abstinence, varenicline was 34% (CA-12) and 31% (CA-24) more effective for women.ConclusionsUnlike other smoking cessation medications, varenicline demonstrated greater efficacy among women smokers for short and immediate-term outcomes and equal efficacy for 1-year outcomes. Varenicline may be particularly useful for reducing the sex disparity typically seen in rates of smoking cessation.ImplicationsVarenicline is currently the most effective FDA-approved smoking cessation medication and this is the first demonstration that women compared with men have a preferred therapeutic response for a smoking cessation medication when considering short-term outcomes. Importantly, this is also the first demonstration that women have similar rates of quitting to men when considering longer-term, 1-year outcomes.

Project description:BackgroundSmoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions.MethodsThis is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups.DiscussionPeople with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates.Trial registrationAustralian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).

Dataset Information

Efficacy of smoking cessation with varenicline plus counselling for e-cigarettes users (VAREVAPE): A protocol for a randomized controlled trial.

Publications

Efficacy of smoking cessation with varenicline plus counselling for e-cigarettes users (VAREVAPE): A protocol for a randomized controlled trial.

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