Integrated Smoking Cessation Treatment for Low Income Community Corrections

Study Overview
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Brief Summary
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This study recruited cigarette smokers under supervision in community corrections (e.g., probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12 weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The study was stratified on race such that equal proportions of African Americans and Caucasians were enrolled in the two study groups. It was hypothesized that smokers receiving intensive counseling will have higher quit rates compared to smokers receiving brief advice to quit.

Official Title
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Integrated Smoking Cessation Treatment for Low Income Community Corrections

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: counseling vs. advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 19 years or older Enrolled in criminal justice community supervision (e.g., probation, parole, drug court, community corrections, etc) Smoking at least 5 cpd for the past year Maintained in an unrestricted environment (e.g., not currently in a correctional facility or treatment facility) living in the Birmingham Area and surrounding communities Exclusion Criteria: Pregnant or nursing (all women in this study will be required to use an acceptable form of contraception throughout the administration of the medication) Known sensitivity to Zyban or Wellbutrin History of seizures Current or prior anorexia or bulimia Abrupt withdrawal from alcohol or benzodiazepines Moderate to severe kidney problems Moderate liver problems Cognitive impairment such that they cannot provide informed consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive counseling<br>4 sessions of intensive counseling plus bupropion | Behavioral: counseling vs. advice<br>* 1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)<br>* Other names: zyban;|
| Active Comparator: Brief Counseling<br>Brief physician advice to quit plus bupropion | Behavioral: counseling vs. advice<br>* 1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)<br>* Other names: zyban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation |  | 3 months | 
| smoking cessation |  | 6 Month | 
| smoking cessation |  | 9 Month | 
| smoking cessation |  | 12 Month |