Buspirone effect on tobacco withdrawal symptoms: a randomized placebo-controlled trial.

BACKGROUND Withdrawal symptoms hinder smoking cessation in nicotine-dependent smokers. This prospective, double-blind, placebo-controlled clinical trial was conducted to evaluate buspirone for nicotine withdrawal symptoms. METHODS Fifty-four heavy smokers (mean 33.1 cigarettes per day for 24 years) were randomly prescribed 30 mg/d of buspirone or placebo beginning 3 weeks before abrupt smoking cessation. Validated nicotine withdrawal and anxiety scales were administered at baseline and serially for 2 weeks after cessation. RESULTS Baseline demographic and nicotine-dependence measures were similar for each group. Three smokers (1 on buspirone, 2 on placebo) dropped out of the protocol prior to the quit date. Both groups had significant withdrawal effects over time (analysis of variance [ANOVA] P = 0.0001). There was a significant buspirone effect on any nicotine withdrawal symptoms (ANOVA, alpha = 0.05). Smokers who relapsed, regardless of group, reported significantly worse craving, irritability, anxiety, and difficulty concentrating than abstainers (P less than 0.05). Relapse rates at follow-up visits were not significantly different between groups. Two-week abstinence rates were 52 percent for placebo and 62 percent for buspirone (chi-square, P = 0.760). CONCLUSIONS In these heavy smokers, buspirone offered no relief from nicotine withdrawal symptoms. Regardless of treatment, relapsing smokers experienced more intense nicotine withdrawal.