Bupropion SR Plus Counseling for Smoking Cessation

Phase 4

Completed

• Conditions: Tobacco Dependence; Smoking
• Interventions: Drug: Active bupropion + counseling; Drug: Placebo medication, No counseling; Drug: Placebo medication + counseling; Drug: Active bupropion, No counseling

• Registration Number: NCT01621009
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2002-10
• Study Completion: 2003-10
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Results First Submitted: 2015-05-27
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Results First Posted: 2016-01-27
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

• Smoke 10 or more cigarettes per day
• Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)
• Motivated to quit smoking (score of 3 on 4-point self-report scale)
• Willing to fulfill study requirements

Exclusion Criteria

• Carbon monoxide breath test score below 9 ppm
• Serious psychopathology (bipolar disorder, psychosis)
• Center for Epidemiologic Studies Depression Scale CES-D)score over 16
• Contraindications for use of bupropion
• History of seizure disorder
• History of eating disorder
• Current heavy drinking
• Risk of pregnancy
• Current breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active bupropion + counseling	Active bupropion + counseling	Active bupropion SR plus eight 10-minute individual counseling sessions.
Placebo medication, No counseling	Placebo medication, No counseling	Placebo bupropion, No counseling, just medication checks
Placebo medication + counseling	Placebo medication + counseling	Placebo bupropion plus eight 10-minute individual counseling sessions
Active bupropion , No counseling	Active bupropion, No counseling	Active bupropion, No counseling, only medication checks

Primary Outcome Measures

Name	Time	Method
7-day Point Prevalence Abstinence From Smoking at 6 Months	6 months	No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Trial Locations

Locations (1)

UW Center for Tobacco Research and Intervention; 🇺🇸 Madison, Wisconsin, United States