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Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India.

ABSTRACT: This study examined changes in tobacco craving, withdrawal, and affect as correlates of efficacy in a phase-2 clinical trial of varenicline for smokeless tobacco dependence in India. Smokeless tobacco users (N = 237) at the All India Institute of Medical Sciences were randomized to placebo or varenicline. Abstinence was defined as cotinine-verified seven-day point prevalence cessation at end of treatment (EOT). General Linear Model repeated measures assessed the effects of treatment condition, time, abstinence state, and interaction effects on changes in craving, withdrawal, positive (PA) and negative affect (NA) from baseline to EOT. All participants showed a significant reduction in withdrawal (p < .001), total craving (p < .001), positive reinforcement (PR) craving (p < .001), and NA (p = .02), and an increase in PA (p = .04) from baseline to EOT. However, there were no differences between placebo and varenicline participants in measures of withdrawal, craving, or affect from baseline to week 3 or at EOT. Significant interactions between time and abstinence state were found for total craving (p = .008), PR craving (p < .001), and withdrawal (p = .001), indicating reductions in these processes among those abstinent vs. those still chewing smokeless tobacco. Additional research is needed concerning the effects of varenicline on craving, withdrawal, and affect among smokeless tobacco users.

SUBMITTER: Jhanjee S

PROVIDER: S-EPMC4699413 | biostudies-literature | 2015 Sep-Oct

REPOSITORIES: biostudies-literature

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Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India.

Jhanjee Sonali S Jain Raka R Jain Veena V Gupta Tina T Mittal Swati S Goelz Patricia P Schnoll Robert A RA

Journal of psychoactive drugs 20150828 4

This study examined changes in tobacco craving, withdrawal, and affect as correlates of efficacy in a phase-2 clinical trial of varenicline for smokeless tobacco dependence in India. Smokeless tobacco users (N = 237) at the All India Institute of Medical Sciences were randomized to placebo or varenicline. Abstinence was defined as cotinine-verified seven-day point prevalence cessation at end of treatment (EOT). General Linear Model repeated measures assessed the effects of treatment condition, t ...[more]

PMID: 26317176

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Project description:ObjectiveTo assess the efficacy and safety of varenicline (a licensed cigarette smoking cessation aid) in helping users of smokeless tobacco to quit.DesignDouble blind, placebo controlled, parallel group, multicentre, randomised controlled trial.SettingMedical clinics (mostly primary care) in Norway and Sweden.ParticipantsMen and women aged ≥18 who used smokeless tobacco at least eight times a day, with no abstinence period over three months within one year before screening, who wanted to quit all tobacco use. Participants were excluded if they used any other form of tobacco (except smokeless tobacco) or medication to stop smoking within three months of screening or had any pre-existing medical or psychiatric condition.InterventionsVarenicline 1 mg twice daily (titrated during the first week) or placebo for 12 weeks, with 14 weeks' follow-up after treatment.Main outcome measuresThe primary end point was the four week continuous abstinence rate at the end of treatment (weeks 9-12) confirmed with cotinine concentration. A secondary end point was continuous abstinence rate for weeks 9-26. Safety and tolerability were also evaluated.Results431 participants (213 varenicline; 218 placebo) were randomised and received at least one dose of study drug. Participants' demographics and baseline use of smokeless tobacco were similar (89% (189) and 90% (196), respectively, were men; mean age in both groups was 43.9; participants used smokeless tobacco products about 15 times a day, and about 80% first used smokeless tobacco within 30 minutes after awakening). Continuous abstinence rate at week 9-12 was higher in the varenicline group than the placebo group (59% (125) v 39% (85); relative risk 1.60, 95% confidence interval 1.32 to 1.87, P<0.001; risk difference 20%; number needed to treat 5). The advantage of varenicline over placebo persisted through 14 weeks of follow-up (continuous abstinence rate at week 9-26 was 45% (95) v 34% (73); relative risk 1.42, 1.08 to 1.79, P=0.012; risk difference 11%; number needed to treat 9). The most common adverse events in the varenicline group compared with the placebo group were nausea (35% (74) v 6% (14)), fatigue (10% (22) v 7% (15)), headache (10% (22) v 9% (20)), and sleep disorder (10% (22) v 7% (15)). Few adverse events led to discontinuation of treatment (9% (19) and 4% (9), respectively), and serious adverse events occurred in two (1%) and three (1%) participants, respectively.ConclusionVarenicline can help people to give up smokeless tobacco and has an acceptable safety profile. The response rate in the placebo group in this study was high, suggesting a population less resistant to treatment than smokers.Trial registrationNCT00717093.

Project description:Combining pharmacotherapies for tobacco-dependence treatment may increase smoking abstinence.To determine efficacy and safety of varenicline and bupropion sustained-release (SR; combination therapy) compared with varenicline (monotherapy) in cigarette smokers.Randomized, blinded, placebo-controlled multicenter clinical trial with a 12-week treatment period and follow-up through week 52 conducted between October 2009 and April 2013 at 3 midwestern clinical research sites. Five hundred six adult (?18 years) cigarette smokers were randomly assigned and 315 (62%) completed the study.Twelve weeks of varenicline and bupropion SR or varenicline and placebo.Primary outcome was abstinence rates at week 12, defined as prolonged (no smoking from 2 weeks after the target quit date) abstinence and 7-day point-prevalence (no smoking past 7 days) abstinence. Secondary outcomes were prolonged and point-prevalence smoking abstinence rates at weeks 26 and 52. Outcomes were biochemically confirmed.At 12 weeks, 53.0% of the combination therapy group achieved prolonged smoking abstinence and 56.2% achieved 7-day point-prevalence smoking abstinence compared with 43.2% and 48.6% in varenicline monotherapy (odds ratio [OR], 1.49; 95% CI, 1.05-2.12; P?=?.03 and OR, 1.36; 95% CI, 0.95-1.93; P?=?.09, respectively). At 26 weeks, 36.6% of the combination therapy group achieved prolonged and 38.2% achieved 7-day point-prevalence smoking abstinence compared with 27.6% and 31.9% in varenicline monotherapy (OR, 1.52; 95% CI, 1.04-2.22; P?=?.03 and OR, 1.32; 95% CI, 0.91-1.91; P?=?.14, respectively). At 52 weeks, 30.9% of the combination therapy group achieved prolonged and 36.6% achieved 7-day point-prevalence smoking abstinence compared with 24.5% and 29.2% in varenicline monotherapy (OR, 1.39; 95% CI, 0.93-2.07; P?=?.11 and OR, 1.40; 95% CI, 0.96-2.05; P?=?.08, respectively). Participants receiving combination therapy reported more anxiety (7.2% vs 3.1%; P?=?.04) and depressive symptoms (3.6% vs 0.8%; P?=?.03).Among cigarette smokers, combined use of varenicline and bupropion, compared with varenicline alone, increased prolonged abstinence but not 7-day point prevalence at 12 and 26 weeks. Neither outcome was significantly different at 52 weeks. Further research is required to determine the role of combination therapy in smoking cessation.clinicaltrials.gov Identifier: http://clinicaltrials.gov/show/NCT00935818.

Project description:BackgroundSmokeless tobacco (SLT) use is associated with multiple adverse health effects. It is prominent in Bangladesh, India, and Pakistan, but disparities in use within and across these countries are not well documented or understood. This study assessed the prevalence, patterns, and correlates of SLT use in these three countries.MethodData came from the Global Adult Tobacco Survey, a household survey of adults aged ≥15 years. Data were collected in 2014 (Pakistan), 2017 (Bangladesh), and India (2016-2017). Current SLT use (nasal or oral use) was defined as reported SLT use daily or less than daily at the time of the survey. Prevalence of both overall and specific SLT types were assessed. Multivariate logistic regression was used to assess correlates of SLT use.ResultsOverall, SLT use among adults ≥15 years of age was 20.6% in Bangladesh, 21.4% in India, and 7.7% in Pakistan, corresponding to 22.0 million SLT users in Bangladesh, 199.4 million in India, and 9.6 million in Pakistan. Among current tobacco users overall, the percentage of those who used SLT was 58.4% (CI: 56.0-60.7) in Bangladesh, 74.7% (CI: 73.4-76.0) in India, and 40.3% (CI: 36.2-44.5) in Pakistan. The most commonly used oral SLT product was Zarda (14.5%) in Bangladesh, Khaini (11.2%) in India, and Naswar (5.1%) in Pakistan. Females had greater odds of SLT use than males in Bangladesh, but lower odds of SLT use than males in India and Pakistan. In all three countries, the odds of SLT use was higher among those 25 years and older, lower education, lower wealth index, and greater exposure to SLT marketing.ConclusionAn estimated 231 million adults aged 15 years or older currently use SLT in Bangladesh, India, and Pakistan, comprising 40.3%-74.7% of overall tobacco product use in these countries. Moreover, marked variations in SLT use exist by population groups. Furthermore, exposure to pro-SLT marketing was found to be associated with higher SLT use compared to non-exposed. It is important that tobacco control strategies address all forms of tobacco product use, including SLT.

Dataset Information

Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India.

Publications

Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India.

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