Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Cigarette Smoking Clinical Trial

— BA-DAS  

Official title:

Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372254
• Other study ID #: RSGT1101101CPPD
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2011
• Est. completion date: May 2015

Study information

• Verified date: May 2022
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Depression
• Drug Use

Intervention

Behavioral:
• 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.
• 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.

Drug:
• Transdermal Nicotine Patch
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.

Locations

Country	Name	City	State
United States	Salvation Army Harbor Light Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, College Park	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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