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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:IntroductionKhaini is a smokeless tobacco (SLT) product commonly used in the South-Asian region. It is the most common smokeless tobacco product used in India, having a prevalence of 11.2% and is used by 104.1 million adults. No scales exist to assess khaini dependence. Existing scales available to assess dependence on smokeless tobacco products are not ideal as these are adapted from cigarette dependence scales and developed for western populations. This study aimed to develop a khaini dependence scale and assess its reliability and validity.MethodsRecommended methods for scale development were followed for item development, scale development and scale evaluation. Scale development was guided by a theoretical framework, a review of existing scales and in-depth interviews with 21 khaini users recruited from a tertiary care hospital in Mumbai, India. The process involved the identification of domains for dependence and the development of an item pool. Cognitive interviews and pre-testing were conducted with 20 khaini users to assess content validity. A cross-sectional survey with 323 khaini users was conducted, and Exploratory Factor Analysis (EFA) was used to determine the factor structure of the draft scale. The content validity, criterion validity (by cross-referencing with the cotinine level of users), convergent validity and internal consistency of the new scale were assessed.ResultsThe final version of the Khaini SLT Dependence Scale (KSLTDS) had 20 items. EFA indicated an acceptable goodness of fit for a three-factor structure with physical, psychological and sociocultural-behavioral sub-scales. It showed evidence of acceptable criterion validity with cotinine (ρ=0.43, p=0.0002), convergent validity with FTND-ST (ρ=0.51, p<0.0001) and frequency of khaini use (ρ=0.38, p<0.0001). The sub-scales (α=0.87-0.90) showed acceptable internal consistency.ConclusionsThe psychometric evaluation of the KSLTDS showed preliminary validity and reliability for assessing dependence on khaini, and therefore, it is appropriate for clinical and research purposes. Re-validation studies are required with various khaini user populations.

Project description:IntroductionAlthough most of the disease burden internationally is due to tobacco smoking, smokeless tobacco (SLT) use contributed to an estimated 76 000 deaths in 2017. We have studied the potential risk factors for SLT use among adolescents in South India.MethodsA cross-sectional questionnaire survey of all students in grades 6-8 in schools in the Udupi district of Karnataka State ascertained SLT use status and potential determinants of SLT uptake. Ever SLT use was defined as any reported consumption of any SLT products, currently or at any time in the past. Independent effects on ever SLT use status were estimated using multiple logistic regression.ResultsOf 46 706 students from 914 participating schools, 39 282 (84.1%) provided questionnaire responses sufficiently complete for analysis. Ever SLT use was reported by 775 (2.0%) participants and in a mutually adjusted model was significantly related to age, male sex, family use, or friend's use of SLT, low socioeconomic status, high rebelliousness, and low self-esteem. After controlling for these effects, the odds of ever-SLT use were significantly higher among students who had least awareness of the harmful effects of tobacco use (odds ratio 3.7, 95% confidence interval [2.9, 4.7]) and significantly lower among those not exposed to tobacco advertising (odds ratio 0.7, 95% confidence interval [0.5, 0.8]).ConclusionsThe prevalence of SLT use among children in Karnataka is relatively low when compared with other studies in India. The significant potential risk factors of SLT use include low awareness of the harmful effects of tobacco and tobacco control policies and exposure to tobacco advertising.ImplicationsThe prevalence of SLT use among school going adolescents in South India is relatively low. The potential risk factors for SLT use among adolescents in southern India are similar to those for smoked tobacco. It includes age, male gender, family or friend's use of SLT, low socioeconomic status, high rebelliousness, low self-esteem, exposure to tobacco advertisement and least awareness about the harmful effects of tobacco and of tobacco control policies. The present study lays emphasis regarding creating awareness about tobacco harms and control policies for further reducing tobacco use among adolescents.

Project description:ImportanceCombining pharmacotherapies for tobacco-dependence treatment may increase smoking abstinence.ObjectiveTo determine efficacy and safety of varenicline and bupropion sustained-release (SR; combination therapy) compared with varenicline (monotherapy) in cigarette smokers.Design, setting, and participantsRandomized, 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.InterventionsTwelve weeks of varenicline and bupropion SR or varenicline and placebo.Main outcomes and measuresPrimary 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.ResultsAt 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).Conclusions and relevanceAmong 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.Trial registrationclinicaltrials.gov Identifier: http://clinicaltrials.gov/show/NCT00935818.

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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