Sustained-release bupropion smoking cessation in African Americans - A randomized controlled trial

Context African Americans disproportionately experience greater smoking attributable morbidity and mortality. Few clinical trials for smoking cessation in African Americans have been conducted, despite a different profile of both smoking and quitting patterns. Objective To compare a sustained-release form of bupropion hydrochloride (bupropion SR) with placebo for smoking cessation among African Americans. Design, Setting, and Participants Randomized, double-blind, placebo-controlled trial conducted from February 11, 1999, to December 8, 2000, of 600 African American adults treated at a community-based health care center. Volunteers, who smoked 10 or more cigarettes per day were recruited by targeted media and health care professionals. Intervention Participants were randomly assigned to receive 150 mg of bupropion SR (n=300) or placebo (n=300) twice daily for 7 weeks. Brief motivational counseling was provided in-person at baseline, quit day, weeks I and 3, end of treatment (week 6), and by telephone at day 3 and weeks 5 and 7. Main Outcome Measures Biochemically confirmed 7-day point prevalence abstinence at weeks 6 and 26 following quit day. Results Using intention-to-treat procedures, confirmed abstinence rates at the end of 7 weeks of treatment were 36.0% in the bupropion SR group and 19.0% in the placebo group (17.0 percentage point difference; 95% confidence interval, 9.7-24.4; P<.001). At 26 weeks the quit rates were 21.0% in the treatment and 13.7% in the placebo groups (7.3 percentage point difference; 95% confidence interval, 1.0-13.7; P=.02). Those taking bupropion SR experienced a greater mean reduction in depression symptoms at week 6 (2.96 [9.45] vs 1.13 [8.84]) than those taking placebo, and after controlling for continuous abstinence, those taking bupropion SR also gained less weight than those taking placebo. Conclusions Bupropion SR was effective for smoking cessation among African Americans and may be useful in reducing the health disparities associated with smoking.