Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Conditions
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Cigarette Smoking, Drug Use

Intervention / Treatment
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* Behavioral: Standard Treatment
* Behavioral: BAD-AS
* Drug: Transdermal Nicotine Patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard smoking cessation<br>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. | Behavioral: Standard Treatment<br>* 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.<br>* Other names: ST;Drug: Transdermal Nicotine Patch<br>* 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.<br>* Other names: Nicoderm CQ;|
| Experimental: BA for substance abusing smokers<br>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. | Behavioral: BAD-AS<br>* 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.<br>Drug: Transdermal Nicotine Patch<br>* 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.<br>* Other names: Nicoderm CQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date | 7 days of smoking abstinence confirmed biochemically at 26 weeks | 26 weeks post quit date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Use, Cigarette Smoking, Depressed Mood