Integrated Smoking Cessation Treatment for Low Income Community Corrections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

689 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-03-31

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.

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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive counseling

4 sessions of intensive counseling plus bupropion

Group Type EXPERIMENTAL

counseling vs. advice

Intervention Type BEHAVIORAL

1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)

Brief Counseling

Brief physician advice to quit plus bupropion

Group Type ACTIVE_COMPARATOR

counseling vs. advice

Intervention Type BEHAVIORAL

1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)

Interventions

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counseling vs. advice

1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)

Intervention Type BEHAVIORAL

Other Intervention Names

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counseling wellbutrin bupropion zyban

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes