Integrated Smoking Cessation Treatment for Low Income Community Corrections
1 other identifier
interventional
689
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 18, 2017
April 1, 2017
4.4 years
October 28, 2010
April 17, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
smoking cessation
3 months
smoking cessation
6 Month
smoking cessation
9 Month
smoking cessation
12 Month
Study Arms (2)
Intensive counseling
EXPERIMENTAL4 sessions of intensive counseling plus bupropion
Brief Counseling
ACTIVE COMPARATORBrief physician advice to quit plus bupropion
Interventions
1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB Substance Abuse
Birmingham, Alabama, 35209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen L Cropsey, Psy.D.
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 28, 2010
First Posted
December 9, 2010
Study Start
October 1, 2009
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
April 18, 2017
Record last verified: 2017-04