Bupropion Alone or Combined With Nicotine Gum

Tobacco Dependence Clinical Trial

Official title:

Efficacy of Bupropion Alone and in Combination With Nicotine Gum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621022
• Other study ID #: IRB S-01-07
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2012
• Last updated: December 5, 2016
• Start date: January 2001
• Est. completion date: October 2002

Study information

• Verified date: December 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 608
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• bupropion + nicotine gum
150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
• Active bupropion-Placebo gum
150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
• Placebo bupropion-Placebo gum
Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)

Locations

Country	Name	City	State
United States	UW Center for Tobacco Research and Intervention	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Piper ME, Federman EB, McCarthy DE, Bolt DM, Smith SS, Fiore MC, Baker TB. Efficacy of bupropion alone and in combination with nicotine gum. Nicotine Tob Res. 2007 Sep;9(9):947-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence measured at 6 months	No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up	6 months	No