Bupropion Alone or Combined With Nicotine Gum

December 5, 2016 updated by: University of Wisconsin, Madison

Efficacy of Bupropion Alone and in Combination With Nicotine Gum

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

608

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • UW Center for Tobacco Research and Intervention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active bupropion-Active gum
150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
Drug: bupropion + nicotine gum
150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
Active Comparator: Active bupropion-Placebo gum
150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
Drug: Active bupropion-Placebo gum
150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
Active Comparator: Placebo medication-Placebo gum
Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)
Drug: Placebo bupropion-Placebo gum
Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

October 1, 2002

Study Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB S-01-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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