Bupropion Alone or Combined With Nicotine Gum

Phase 4

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: bupropion + nicotine gum; 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

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2002-10
• Study Completion: 2002-10
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

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

Group	Intervention	Description
Active bupropion-Active gum	bupropion + nicotine gum	150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
Active bupropion-Placebo gum	Active bupropion-Placebo gum	150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
Placebo medication-Placebo gum	Placebo bupropion-Placebo gum	Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)

Primary Outcome Measures

Name	Time	Method
7-day point prevalence abstinence measured at 6 months	6 months	No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up

Trial Locations

Locations (1)

UW Center for Tobacco Research and Intervention; 🇺🇸 Madison, Wisconsin, United States