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Integrated Smoking Cessation Treatment for Low Income Community Corrections

This study is currently recruiting participants.
Verified December 2012 by University of Alabama at Birmingham
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01257490
First received: October 28, 2010
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is recruiting cigarette smokers under supervision in community corrections (e.g., probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers will either receive 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. Equal numbers of Caucasian and African-Americans will be recruited for this study. It is hypothesized that smokers receiving intensive counseling will have higher quit rates compared to smokers receiving brief advice to quit.


Condition Intervention
Smoking Cessation
 Behavioral: counseling vs. advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Smoking Cessation Treatment for Low Income Community Corrections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • smoking cessation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • smoking cessation [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
  • smoking cessation [ Time Frame: 9 Month ] [ Designated as safety issue: No ]
  • smoking cessation [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • wellbutrin
  • bupropion
  • 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
  • wellbutrin
  • bupropion
  • zyban

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257490

Contacts
Contact: Sonya Hardy, B.S. 205-917-3786 ext 220 lekeesha@uab.edu

Locations
United States, Alabama
UAB Substance Abuse Recruiting
Birmingham, Alabama, United States, 35209
Contact: Sonya Hardy, B.S.     205-917-3786 ext 220        
Principal Investigator: Karen Cropsey, Psy.D.            
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen L Cropsey, Psy.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Karen Cropsey, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01257490     History of Changes
Other Study ID Numbers: R01CA141663, R01CA141663-01
Study First Received: October 28, 2010
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Smoking
Habits
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013