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

University of Maryland

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cigarette Smoking; Drug Use

Treatments: Behavioral: Standard Treatment; Drug: Transdermal Nicotine Patch; Behavioral: BAD-AS

Study type: Interventional

Funder types: Other

Identifiers

NCT01372254

RSGT1101101CPPD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Standard smoking cessation

Active Comparator group

Description:

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.

Treatment:

Drug: Transdermal Nicotine Patch

Behavioral: Standard Treatment

BA for substance abusing smokers

Experimental group

Description:

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.

Treatment:

Behavioral: BAD-AS

Drug: Transdermal Nicotine Patch