Bupropion SR Plus Counseling for Smoking Cessation
Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tobacco Dependence; Smoking
Intervention: Active bupropion + counseling (Drug); Active bupropion, No counseling (Drug); Placebo medication + counseling (Drug); Placebo medication, No counseling (Drug); Placebo medication, No counseling (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s): Timothy B Baker, PhD, Principal Investigator, Affiliation: University of Wisconsin, Madison Timothy B Baker, PhD, Study Director, Affiliation: University of Wisconsin, Madison
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.
Clinical Details
Official title: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: 7-day point prevalence abstinence from smoking at 6 months
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
UW Center for Tobacco Research and Intervention, Madison, Wisconsin 53711, United States
Additional Information
Starting date: January 2001
Last updated: June 14, 2012
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