NCT01621022CompletedPhase 4
Efficacy of Bupropion Alone and in Combination With Nicotine Gum
University of Wisconsin, Madison1 site in 1 country608 target enrollmentStarted: January 2001Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 608
- Locations
- 1
- Primary Endpoint
- 7-day point prevalence abstinence measured at 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Active bupropion-Active gum
Active Comparator
150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
Intervention: bupropion + nicotine gum (Drug)
Active bupropion-Placebo gum
Active Comparator
150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
Intervention: Active bupropion-Placebo gum (Drug)
Placebo medication-Placebo gum
Active Comparator
Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)
Intervention: Placebo bupropion-Placebo gum (Drug)
Outcomes
Primary Outcomes
7-day point prevalence abstinence measured at 6 months
Time Frame: 6 months
No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Combinations of Pharmacologic Smoking Cessation TreatmentsSmokingNCT00018187US Department of Veterans Affairs
Completed
Phase 4
Bupropion as an Adjunct to the Nicotine Patch Plus CBTTobacco Use DisorderNCT00142831National Institute on Drug Abuse (NIDA)293
Completed
Phase 4
A Comparison of Bupropion SR and Placebo for Smoking CessationTobacco Use DisorderNCT00176449University of Maryland, Baltimore52
Terminated
Phase 2
High Dose Bupropion for Smoking Cessation - Pilot StudySmoking CessationSmoking, TobaccoSmoking (Tobacco) AddictionCessation, TobaccoCigarette SmokingNCT03326128University of Southern California12
Terminated
Not Applicable
Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office PracticeSmoking CessationNCT01850589Northwell Health44