Abstract
BACKGROUND: Pharmacotherapies have been shown to increase tobacco abstinence rates among smokeless tobacco (ST) users. Bupropion SR has demonstrated potential efficacy for ST users in pilot studies. We conducted a randomized, clinical trial to assess the efficacy and safety of bupropion SR for tobacco abstinence among ST users. METHODS: Adult ST users were randomized to bupropion SR titrated to 150 mg twice daily (N= 32) for 12 weeks. The primary endpoint was the 7-day point-prevalence tobacco abstinence rate at 6 week. Secondary outcomes included prolonged and continuous tobacco abstinence rates, craving and nicotine withdrawal, at week 8 and week 12. RESULTS: The 7-day point-prevalence tobacco abstinence rates with bupropion SR at week 6 (28.1%), week 8 (28.1%) and week 12 (28.1%); p = 0.0003). The prolonged and continuous tobacco abstinence rates did not differ at weeks 6, 8, and 12. The treatment response was observed over time with FTND-ST scale. At 12 weeks, the mean (±SD) FTND-ST score change from baseline among abstinent subjects was a decrease of 2.66 (±1.52) for the bupropion SR group. CONCLUSIONS: Bupropion SR did significantly increase tobacco abstinence rates among ST users, as well as it significantly decreased craving over the treatment period.