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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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