Varenicline versus Bupropion XL for Smoking Cessation in Older Adolescents: A Randomized, Double-Blind Pilot Trial

INTRODUCTION: Despite tremendous potential public health impact, little work has focused on development of evidence-based smoking cessation treatments for adolescents, including pharmacotherapies. No prior studies have explored the feasibility and safety of varenicline and bupropion XL, 2 potentially promising pharmacotherapies, as smoking cessation treatments in adolescents. METHODS: Treatment-seeking older adolescent smokers (ages 15-20) were randomized (double-blind) to varenicline (n = 15) or bupropion XL (n = 14), with 1-week titration and active treatment for 7 weeks. Structured safety, tolerability, and efficacy assessments (cotinine-confirmed 7-day point prevalence abstinence) were conducted weekly. RESULTS: There were no serious adverse events. Two participants discontinued bupropion XL due to adverse effects, and none discontinued varenicline. Over the course of treatment, participants receiving varenicline reduced from 14.1 ± 6.3 (mean ± SD) to 0.9 ± 2.1 cigarettes/day (CPD, 4 achieved abstinence), while those receiving bupropion XL reduced from 15.8 ± 4.4 to 3.1 ± 4.0 CPD (2 achieved abstinence). CONCLUSIONS: These preliminary results support the feasibility and safety of conducting adequately powered, placebo-controlled efficacy studies of varenicline and bupropion XL for adolescent smoking cessation.