Smokeless Tobacco Clinical Trial
Official title:
Bupropion SR for Treating Smokeless Tobacco Use
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.
CONTEXT: No pharmacotherapies have been shown to increase long-term (≥ 6 month)
tobacco abstinence rates among smokeless tobacco (ST) users, although bupropion SR has
demonstrated potential efficacy in pilot studies.
OBJECTIVE: To determine the efficacy and safety of bupropion SR for tobacco abstinence among
ST users compared with placebo.
DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial
conducted between August 2003 to May 2005 at two research centers with a 12-week treatment
period and follow-up of smoking status to week 52.
INTERVENTION: Bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks plus
weekly behavioral interventions.
Main Outcome Measures: The primary endpoint was 7-day point-prevalence tobacco abstinence
rate at week 12. Secondary outcomes included the prolonged and continuous tobacco abstinence
rates at weeks 12, 24, and 52.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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