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Bupropion Alone or Combined With Nicotine Gum

Phase 4
Completed
Conditions
Tobacco Dependence
Interventions
Drug: Active bupropion-Placebo gum
Drug: Placebo bupropion-Placebo gum
Registration Number
NCT01621022
Lead Sponsor
University of Wisconsin, Madison
Brief Summary

Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
608
Inclusion Criteria
  • Smoke 10 or more cigarettes per day
  • Motivated to quit
  • No physical or mental health issues that would prevent participation
  • Not pregnant or willing to prevent pregnancy during treatment
Exclusion Criteria
  • Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
  • Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
  • Heavy alcohol use
  • History of eating disorder
  • Suicidality

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active bupropion-Active gumbupropion + nicotine gum150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
Active bupropion-Placebo gumActive bupropion-Placebo gum150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
Placebo medication-Placebo gumPlacebo bupropion-Placebo gumPlacebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)
Primary Outcome Measures
NameTimeMethod
7-day point prevalence abstinence measured at 6 months6 months

No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

UW Center for Tobacco Research and Intervention

🇺🇸

Madison, Wisconsin, United States

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