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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by University of Maryland
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01372254
First received: June 10, 2011
Last updated: July 12, 2011
Last verified: July 2011

June 10, 2011
July 12, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01372254 on ClinicalTrials.gov Archive Site
Changes in Mood and Depressive Symptoms [ Time Frame: Baseline to 26 weeks post quit date ] [ Designated as safety issue: No ]
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.
    Other Name: BAD-AS
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Behavioral: BAD-AS
    • Drug: Transdermal Nicotine Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
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
Both
18 Years to 65 Years
No
Contact: Laura MacPherson, PhD lmacpherson@psyc.umd.edu
Contact: Elana Hoffman, B.A. ehoffma5@psyc.umd.edu
United States
 
NCT01372254
RSGT1101101CPPD
No
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