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Bupropion Alone or Combined With Nicotine Gum

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion + nicotine gum
Active bupropion-Placebo gum
Placebo bupropion-Placebo gum
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring smoking cessation, tobacco dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UW Center for Tobacco Research and Intervention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Active bupropion-Active gum

Active bupropion-Placebo gum

Placebo medication-Placebo gum

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 13, 2012
Last Updated
December 5, 2016
Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01621022
Brief Title
Bupropion Alone or Combined With Nicotine Gum
Official Title
Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
smoking cessation, tobacco dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
608 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active bupropion-Active gum
Arm Type
Active Comparator
Arm Description
150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
Arm Title
Active bupropion-Placebo gum
Arm Type
Active Comparator
Arm Description
150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
Arm Title
Placebo medication-Placebo gum
Arm Type
Active Comparator
Arm Description
Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)
Intervention Type
Drug
Intervention Name(s)
bupropion + nicotine gum
Intervention Description
150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
Intervention Type
Drug
Intervention Name(s)
Active bupropion-Placebo gum
Intervention Description
150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
Intervention Type
Drug
Intervention Name(s)
Placebo bupropion-Placebo gum
Intervention Description
Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)
Primary Outcome Measure Information:
Title
7-day point prevalence abstinence measured at 6 months
Description
No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UW Center for Tobacco Research and Intervention
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17763111
Citation
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. doi: 10.1080/14622200701540820.
Results Reference
result

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Bupropion Alone or Combined With Nicotine Gum

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