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Bupropion Alone or Combined With Nicotine Gum

Efficacy of Bupropion Alone and in Combination With Nicotine Gum

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01621022
Enrollment
608
Registered
2012-06-15
Start date
2001-01-31
Completion date
2002-10-31
Last updated
2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Dependence

Keywords

smoking cessation, tobacco dependence

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.

Interventions

DRUGPlacebo bupropion-Placebo gum

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

DRUGbupropion + nicotine gum

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

DRUGActive bupropion-Placebo gum

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
7-day point prevalence abstinence measured at 6 months6 monthsNo smoking, not evan a puff, during the 7 days prior to the 6 month follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026