Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation.

Author(s): Muramoto ML, Leischow SJ, Sherrill D, Matthews E, Strayer LJ

Affiliation(s): Department of Family and Community Medicine, The University of Arizona College of Medicine, Tucson, AZ 85704, USA. myram@email.arizona.edu

Publication date & source: 2007-11, Arch Pediatr Adolesc Med., 161(11):1068-74.

Publication type: Clinical Trial, Phase III; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

OBJECTIVE: To assess the safety and efficacy of sustained-release bupropion hydrochloride for adolescent smoking cessation. DESIGN: Prospective, randomized, double-blind, placebo-controlled, dose-ranging trial. SETTING: Metropolitan areas of Tucson and Phoenix, Arizona. PARTICIPANTS: Adolescents (N = 312) recruited through media and various community venues from March 1, 1999, through December 31, 2002, who were aged 14 to 17 years, smoked 6 or more cigarettes per day, had an exhaled carbon monoxide level of 10 ppm or greater, had at least 2 previous quit attempts, and had no other current major psychiatric diagnosis. INTERVENTION: Sustained-release bupropion hydrochloride, 150 mg/d (n = 105) or 300 mg/d (n = 104), or placebo (n = 103) for 6 weeks, plus weekly brief individual counseling. Subjects were followed up at 12 weeks (by telephone call) and 26 weeks. MAIN OUTCOME MEASURE: Confirmed 7-day point prevalence abstinence at 6 weeks and 30-day prolonged abstinence (carbon monoxide level < 10 ppm at each visit; urinary cotinine level < or = 50 microg/L at weeks 2 and 6). RESULTS: Cotinine-confirmed 7-day point prevalence abstinence rates at 6 weeks were as follows: placebo, 5.6%; 150 mg, 10.7%; and 300 mg, 14.5% (P = .03, 300 mg vs placebo). At 26 weeks, confirmed point prevalence abstinence rates were as follows: placebo, 10.3%; 150 mg, 3.1%; and 300 mg, 13.9% (P = .049). During treatment, confirmed point prevalence rates were significantly higher for 300 mg than placebo at every week except week 4. CONCLUSIONS: Sustained-release bupropion hydrochloride, 300 mg/d, plus brief counseling demonstrated short-term efficacy for adolescent smoking cessation. Abstinence rates were lower than those reported for adults, with rapid relapse after medication discontinuation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00344695.