Clinical trial NCT01372254: Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
Official title: Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cigarette Smoking
Drug Use
Keywords: Cigarette Smoking
Drug Use
Depressed Mood
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2011-06-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date
timeFrame: 26 weeks post quit date
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Salvation Army Harbor Light Center
state: District of Columbia
Study officials:
affiliation: University of Maryland
name: Laura MacPherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: