NCT00414180

Bupropion SR for Treating Smokeless Tobacco Use

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (planned)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.

Detailed description

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.

Conditions

• Smokeless Tobacco

Interventions

Type	Name	Description
DRUG	Bupropion SR

Timeline

• Start date: 2003-08-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2006-12-21
• Last updated: 2011-03-14

Locations

1 site across 1 country: United States