The 13th World Conference on Tobacco OR Health

Objective: To evaluate the effect of varenicline, a novel, selective α4β2 receptor partial agonist, on craving and withdrawal symptoms associated with smoking cessation.

Methods: Subjects received varenicline 1 mg bid or placebo for smoking cessation in two randomized, double-blind, studies with the same design (at different sites). In addition to smoking cessation efficacy endpoints, symptoms of craving and withdrawal were assessed using two self-administered outcomes questionnaires: the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief Questionnaire of Smoking Urges (QSU-Brief) at baseline and over the following 7 of 12 weeks of treatment. The most important pre-specified domains of interest were Urge to Smoke/Craving, Negative Affect and Restlessness for the MNWS and Total Craving Score for the QSU-Brief.

Results: Results demonstrated that varenicline was statistically significantly more effective than placebo in reducing craving and withdrawal over the 7 weeks as measured by: MNWS Urge to smoke (p<0.0001, both trials) with standardized effect size (ES; in absolute value) of 0.67 (study 1) and 0.63 (study 2) and QSU Total Craving Score (p<.0001, both trials) with ES of 0.33 in both studies. Varenicline was more effective than placebo in reducing withdrawal symptoms: MNWS Negative affect, with ES of 0.30 (p=0.0011) (study 1) and ES of 0.21 (p<0.0001) (study 2). For Restlessness, only the second study reached statistical significance ES (p < 0.05); effect sizes were 0.16 (study 1) and 0.11 (study 2). Results demonstrate that varenicline significantly reduces craving and withdrawal during the first 7 weeks of smoking cessation compared with placebo.