Abstract
Background.—Preliminary information suggests that buspirone hydrochloride ameliorates symptoms of nicotine withdrawal. In a double-blind, randomized, placebocontrolled trial, we determined the effects of buspirone on the withdrawal symptoms associated with smoking cessation in 40 long-term cigarette smokers. Methods.—Subjects Subjects were randomized to 4 weeks of treatment with either buspirone (n = 20) or placebo (n = 20). Subjects were instructed to maintain their usual cigarette intake during the first 21 days of treatment and to cease smoking on day 22 of treatment. Withdrawal symptoms were subjectively rated before and during smoking cessation. Results.—Before smoking cessation, there were no significant differences in the intensity of any withdrawal symptom between the buspirone- and placebo-treated subjects, with the exception of a significantly higher rating for drowsiness in the buspirone group. During the smoking cessation period, the ratings for craving, anxiety, irritability, restlessness, and sadness were significantly lower in the buspirone group than the placebo group. there were no significant differences between the groups in their ratings for hunger, inability to concentrate, or drowsiness. Fifteen buspirone-treated subjects and nine placebo-treated subjects were able to abstain from cigarettes during the entire 7-day smoking cessation period. No subject dropped out of the study for perceived drug side effects. Eight buspironetreated subjects and five placebo-treated subjects reported side effects, all of which were mild. Conclusions.—Buspirone ameliorated most of the shortterm withdrawal symptoms associated with smoking cessation. Further controlled studies will be needed to define the benefit in smoking cessation.