Bupropion SR Plus Counseling for Smoking Cessation

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling

Conditions
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Tobacco Dependence, Smoking

Intervention / Treatment
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* Drug: Active bupropion + counseling
* Drug: Active bupropion, No counseling
* Drug: Placebo medication + counseling
* Drug: Placebo medication, No counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active bupropion + counseling<br>Active bupropion SR plus eight 10-minute individual counseling sessions. | Drug: Active bupropion + counseling<br>* Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks. Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date.<br>|
| Active Comparator: Active bupropion , No counseling<br>Active bupropion, No counseling, only medication checks | Drug: Active bupropion, No counseling<br>* Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day. Counseling: No cessation counseling, only medication checks<br>|
| Placebo Comparator: Placebo medication + counseling<br>Placebo bupropion plus eight 10-minute individual counseling sessions | Drug: Placebo medication + counseling<br>* Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day. Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day.<br>|
| Placebo Comparator: Placebo medication, No counseling<br>Placebo bupropion, No counseling, just medication checks | Drug: Placebo medication, No counseling<br>* Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day. Counseling: No counseling, just medication checks<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation medications, smoking cessation counseling