Integrated Smoking Cessation Treatment for Low Income Community Corrections

April 17, 2017 updated by: Karen Cropsey, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

689

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • UAB Substance Abuse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive counseling
4 sessions of intensive counseling plus bupropion
Behavioral: 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)
Other Names:
  • counseling
  • bupropion
  • wellbutrin
  • zyban
Active Comparator: Brief Counseling
Brief physician advice to quit plus bupropion
Behavioral: 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)
Other Names:
  • counseling
  • bupropion
  • wellbutrin
  • zyban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
smoking cessation
Time Frame: 3 months
3 months
smoking cessation
Time Frame: 6 Month
6 Month
smoking cessation
Time Frame: 9 Month
9 Month
smoking cessation
Time Frame: 12 Month
12 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen L Cropsey, Psy.D., University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA141663 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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