Bupropion Alone or Combined With Nicotine Gum

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Tobacco Dependence

Treatments: Drug: Placebo bupropion-Placebo gum; Drug: Active bupropion-Placebo gum; Drug: bupropion + nicotine gum

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01621022

IRB S-01-07

Details and patient eligibility

About

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

Enrollment: 608 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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608 participants in 3 patient groups

Active bupropion-Active gum

Active Comparator group

Description:

150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)

Treatment:

Drug: bupropion + nicotine gum

Active bupropion-Placebo gum

Active Comparator group

Description:

150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)

Treatment:

Drug: Active bupropion-Placebo gum

Placebo medication-Placebo gum

Active Comparator group

Description:

Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)

Treatment:

Drug: Placebo bupropion-Placebo gum