Bupropion SR for Treating Smokeless Tobacco Use
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414180
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Lowell C. Dale, M.D.||Mayo Clinic|