Bupropion SR for Treating Smokeless Tobacco Use
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smokeless Tobacco
Intervention: Bupropion SR (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Lowell C. Dale, M.D., Principal Investigator, Affiliation: Mayo Clinic
Summary
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless
tobacco users.
Clinical Details
Official title: Bupropion SR for Treating Smokeless Tobacco Use
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 7-day point-prevalence tobacco abstinence rate at week 12
Secondary outcome: prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years of age or older
- used ST daily for at least one year
- in good general health
- willing to complete all study procedures
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: August 2003
Ending date: May 2005
Last updated: December 20, 2006
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