The efficacy of the combination of sertraline with buspirone for smoking cessation. A randomized clinical trial in nondepressed smokers.

In a double-blind placebo-controlled trial, we evaluated the efficacy of the combination of sertraline and buspirone plus cognitive-behavioral treatment to promote tobacco abstinence in individuals referred to a chemical dependency clinic. Ninety eight individuals 18-65 years of age were randomized to placebo or sertraline 25 mg/day for 2 days, followed by 50 mg from day 3 to 90, and buspirone 5 mg three times a day for 7 days, and 10 mg from day 8 to 90. The rate of continuous abstinence at the 26th week of follow-up, informed by the patient, was 43.5% in the active treatment group and 17.3% in the control group (p = 0.01). The odds ratio for continuous abstinence for the intervention group was 4.74 (95% CI 1.50-14.55) (adjusted for smoker households and number of cognitive sessions). Nicotine withdrawal symptoms were common in both groups (98.7% vs. 95.5% p = 0.37). The combination of sertraline and buspirone with cognitive-behavioral therapy was more effective than placebo and cognitive-behavioral therapy to promote smoking cessation.