Bupropion SR for Treating Smokeless Tobacco Use
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Bupropion SR for Treating Smokeless Tobacco Use|
- 7-day point-prevalence tobacco abstinence rate at week 12
- prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52
|Study Start Date:||August 2003|
|Study Completion Date:||May 2005|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
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.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Lowell C. Dale, M.D.||Mayo Clinic|