Bupropion SR for Treating Smokeless Tobacco Use
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|ClinicalTrials.gov Identifier: NCT00414180|
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : March 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Smokeless Tobacco||Drug: Bupropion SR||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Bupropion SR for Treating Smokeless Tobacco Use|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
- 7-day point-prevalence tobacco abstinence rate at week 12
- prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414180
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Lowell C. Dale, M.D.||Mayo Clinic|