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Completed

NCT Number: NCT01372254

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Salvation Army Harbor Light Center

Washington D.C., District of Columbia, 20002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard treatment

Behavioral

Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.

Other names: ST

BAD-AS

Behavioral

The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.

Transdermal Nicotine Patch

Drug

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. Participants in both intervention arms will receive transdermal nicotine patch.

Other names: Nicoderm CQ

Primary outcomes

  1. Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date

    Time frame: 26 weeks post quit date

    7 days of smoking abstinence confirmed biochemically at 26 weeks

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Acronym: BA-DAS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 13, 2011
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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