Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
18 Years
65 Years
Both
Cigarette Smoking, Drug Use
Trial Information
Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
This project will take place in two phases. In the first phase, the investigators will
utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two
existing behavioral activation manuals to develop the Behavioral Activation for Drug Abusing
Smokers (BA-DAS). In Phase II, the investigators will randomize 80 patients to either: 1)
standard smoking cessation treatment (ST) and nicotine replacement therapy (NRT) or 2)
BA-DAS (which includes ST and NRT). Based on the outcome of this preliminary trial, the
BA-DAS protocol will be further refined and readied for larger-scale clinical trials to
develop a comprehensive approach to treating smoking among low income, largely minority,
depressed smokers in residential drug use treatment, which may be instrumental in reducing
smoking among this especially at risk group.
Inclusion Criteria:
- between 18 and 65 years of age
- regular smoker for at least one year
- currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or Black and
Milds included) per day
- report motivation to quit smoking in the next month
- report elevated depressive symptoms
Exclusion Criteria:
- physical concerns contraindicating the nicotine patch
- limited mental competency and/or the inability to give informed, voluntary, written
consent to participate
- current use of pharmacotherapy for smoking cessation not provided by the researchers
during the quit attempt
- use of psychotropic medication for < 3 months
- primary use of other tobacco products (specifically: chewing tobacco, cigars, and
pipes)
- psychotic symptoms
- current pregnancy or plans to become pregnant within the following three months
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Smoking abstinence based on expired carbon monoxide tests, saliva cotinine tests, and self-report
Outcome Time Frame:
26 weeks post quit date
Safety Issue:
No
Principal Investigator
Laura MacPherson, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Maryland College Park, Center for Addictions, Personality, and Emotions Research (CAPER)
Authority:
United States: Institutional Review Board
Study ID:
RSGT1101101CPPD
NCT ID:
NCT01372254
Start Date:
January 2011
Completion Date:
December 2014
Related Keywords:
- Cigarette Smoking
- Drug Use
- Cigarette Smoking
- Drug Use
- Depressed Mood
- Smoking
- Depression
Name | Location |
|---|---|
| Salvation Army Harbor Light Center | Washington, District of Columbia 20002 |
