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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking
Drug Use
 Behavioral: Standard Treatment
Behavioral: BAD-AS
Drug: Transdermal Nicotine Patch
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in Mood and Depressive Symptoms [ Time Frame: Baseline to 26 weeks post quit date ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372254

Contacts
Contact: Laura MacPherson, PhD lmacpherson@psyc.umd.edu
Contact: Elana Hoffman, B.A. ehoffma5@psyc.umd.edu

Locations
United States, District of Columbia
Salvation Army Harbor Light Center Recruiting
Washington, District of Columbia, United States, 20002
Sponsors and Collaborators
University of Maryland
American Cancer Society, Inc.
Investigators
Principal Investigator: Laura MacPherson, PhD University of Maryland College Park, Center for Addictions, Personality, and Emotions Research (CAPER)
  More Information

No publications provided

Responsible Party: Dr. Laura MacPherson, University of Maryland
ClinicalTrials.gov Identifier: NCT01372254     History of Changes
Other Study ID Numbers: RSGT1101101CPPD
Study First Received: June 10, 2011
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Cigarette Smoking
Drug Use
Depressed Mood

Additional relevant MeSH terms:
Smoking
Depression
Habits
Behavioral Symptoms
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013