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.
Robinson
M D
MD
Department of Family Practice, Carolinas Medical Center, Charlotte, NC 28232-2861.
Pettice
Y L
YL
Smith
W A
WA
Cederstrom
E A
EA
Sutherland
D E
DE
Davis
H
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002065:Buspirone / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000009:adverse effects*; D011446:Prospective Studies; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*; D013997:Time Factors
D009538:Nicotine; D002065:Buspirone