Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
225 participants
INTERVENTIONAL
2003-08-31
2005-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Bupropion SR
Eligibility Criteria
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Inclusion Criteria
* used ST daily for at least one year
* in good general health
* willing to complete all study procedures
18 Years
ALL
Yes
Sponsors
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West Virginia University
OTHER
Mayo Clinic
OTHER
Principal Investigators
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Lowell C. Dale, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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R01 9088
Identifier Type: -
Identifier Source: secondary_id
06-007293
Identifier Type: -
Identifier Source: org_study_id
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