Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Phase 1

Completed

• Conditions: Drug Use; Cigarette Smoking
• Interventions: Behavioral: Standard Treatment; Behavioral: BAD-AS; Drug: Transdermal Nicotine Patch

• Registration Number: NCT01372254
• Lead Sponsor: University of Maryland, College Park

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Study Start: 2011-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2020-08-24
• Results First Submitted QC: 2020-08-24
• Results First Posted: 2020-09-14
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard smoking cessation	Standard Treatment	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.
BA for substance abusing smokers	BAD-AS	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.
BA for substance abusing smokers	Transdermal Nicotine Patch	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.
Standard smoking cessation	Transdermal Nicotine Patch	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date	26 weeks post quit date	7 days of smoking abstinence confirmed biochemically at 26 weeks

Trial Locations

Locations (1)

Salvation Army Harbor Light Center; 🇺🇸 Washington, District of Columbia, United States