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Integrated Smoking Cessation Treatment for Low Income Community Corrections

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Smoking Cessation

Treatments

Behavioral: counseling vs. advice

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01257490
R01CA141663 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

689 patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

689 participants in 2 patient groups

Intensive counseling
Experimental group
Description:
4 sessions of intensive counseling plus bupropion
Treatment:
Behavioral: counseling vs. advice
Brief Counseling
Active Comparator group
Description:
Brief physician advice to quit plus bupropion
Treatment:
Behavioral: counseling vs. advice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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