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
PHASE4
608 participants
INTERVENTIONAL
2001-01-31
2002-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active bupropion-Active gum
150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
bupropion + nicotine gum
150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
Active bupropion-Placebo gum
150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
Active bupropion-Placebo gum
150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
Placebo medication-Placebo gum
Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)
Placebo bupropion-Placebo gum
Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)
Interventions
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bupropion + nicotine gum
150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
Active bupropion-Placebo gum
150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
Placebo bupropion-Placebo gum
Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)
Eligibility Criteria
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Inclusion Criteria
* Motivated to quit
* No physical or mental health issues that would prevent participation
* Not pregnant or willing to prevent pregnancy during treatment
Exclusion Criteria
* Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
* Heavy alcohol use
* History of eating disorder
* Suicidality
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Locations
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UW Center for Tobacco Research and Intervention
Madison, Wisconsin, United States
Countries
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References
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Piper ME, Federman EB, McCarthy DE, Bolt DM, Smith SS, Fiore MC, Baker TB. Efficacy of bupropion alone and in combination with nicotine gum. Nicotine Tob Res. 2007 Sep;9(9):947-54. doi: 10.1080/14622200701540820.
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
Other Identifiers
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IRB S-01-07
Identifier Type: -
Identifier Source: org_study_id