A Phase 3 interventional study of Bupropion SR in Smokeless Tobacco, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-14.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Inclusion Criteria:
7-day point-prevalence tobacco abstinence rate at week 12
prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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