title: 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.
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Sonali
authors: S
authors: Jhanjee
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Raka
authors: R
authors: Jain
authors: b Centre for Dental Education and Research , All India Institute of Medical Sciences , New Delhi , India.
authors: Veena
authors: V
authors: Jain
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Tina
authors: T
authors: Gupta
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Swati
authors: S
authors: Mittal
authors: c Department of Psychiatry and Abramson Cancer Center , University of Pennsylvania , Philadelphia , PA.
authors: Patricia
authors: P
authors: Goelz
authors: c Department of Psychiatry and Abramson Cancer Center , University of Pennsylvania , Philadelphia , PA.
authors: Robert A
authors: RA
authors: Schnoll
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects*; D066249:Craving / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D018722:Nicotinic Agonists / Q000627:therapeutic use*; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*; D020340:Tobacco Use Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000188:drug therapy; D000068580:Varenicline / Q000627:therapeutic use*
chemical_list: D018722:Nicotinic Agonists; D000068580:Varenicline
keywords: intervention; smokeless tobacco; treatment; varenicline