Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment (BA-DAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01372254
Recruitment Status : Unknown
Verified July 2011 by University of Maryland.
Recruitment status was:  Recruiting
First Posted : June 13, 2011
Last Update Posted : July 13, 2011
American Cancer Society, Inc.
Information provided by:
University of Maryland

June 10, 2011
June 13, 2011
July 13, 2011
January 2011
December 2014   (Final data collection date for primary outcome measure)
Smoking abstinence based on expired carbon monoxide tests, saliva cotinine tests, and self-report [ Time Frame: 26 weeks post quit date ]
Same as current
Complete list of historical versions of study NCT01372254 on Archive Site
Changes in Mood and Depressive Symptoms [ Time Frame: Baseline to 26 weeks post quit date ]
Same as current
Not Provided
Not Provided
Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
The objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms. The approach utilizes behavioral activation strategies which have been shown to reduce smoking among community samples and which can be easily targeted for the particular needs of low income substance users.
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.
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Cigarette Smoking
  • Drug Use
  • Behavioral: Standard Treatment
    Participants will receive a standard, individual smoking cessation treatment, based on the most recent clinical practice guideline for treating tobacco use from the U.S. Department of Health and Human Services. Treatment will be delivered in 5, 90-minute group sessions over an 4-5 week period. Patients in ST will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events as a means to equate for time spent on daily activity monitoring in the BAD-AS condition.
    Other Name: ST
  • Behavioral: BAD-AS
    BAD-AS is focused on identifying life areas, values, and daily activities to help one live according to his or her values. Treatment will be delivered in 5, 90-minute individual sessions over a 4-5 week period.
  • Drug: Transdermal Nicotine Patch
    8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
    Other Name: Nicoderm CQ
  • Active Comparator: Standard smoking cessation treatment (ST)
    Participants will receive a standard, group smoking cessation treatment based on the most recent clinical practice guideline from USDHHS, Treating Tobacco Use and Dependence. Treatment will be delivered in five, 90-minute individual sessions, and 2, 4, 8, 16, and 26 weeks post quit.
    • Behavioral: Standard Treatment
    • Drug: Transdermal Nicotine Patch
  • Experimental: Behavioral Activation for Substance Abusing Smokers (BA-DAS)
    The BA-DAS treatment protocol will incorporate elements of the ST and NRT along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions and 2, 4, 8, 16, and 26 weeks post-quit.
    • Behavioral: BAD-AS
    • Drug: Transdermal Nicotine Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Dr. Laura MacPherson, University of Maryland
University of Maryland
American Cancer Society, Inc.
Principal Investigator: Laura MacPherson, PhD University of Maryland College Park, Center for Addictions, Personality, and Emotions Research (CAPER)
University of Maryland
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP