Integrated Smoking Cessation Treatment for Low Income Community Corrections

Smoking Cessation Clinical Trial

Official title:

Integrated Smoking Cessation Treatment for Low Income Community Corrections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257490
• Other study ID #: R01CA141663
• Secondary ID: R01CA141663
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: April 17, 2017
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: April 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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)

Locations

Country	Name	City	State
United States	UAB Substance Abuse	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking cessation		3 months
Primary	smoking cessation		6 Month
Primary	smoking cessation		9 Month
Primary	smoking cessation		12 Month