Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
BA-DAS
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
September 14, 2020
CompletedMay 18, 2022
May 1, 2022
3.4 years
June 10, 2011
August 24, 2020
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Standard smoking cessation
ACTIVE COMPARATORParticipants 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
EXPERIMENTALThe 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Salvation Army Harbor Light Center
Washington D.C., District of Columbia, 20002, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura MacPherson
- Organization
- University of Maryland
Study Officials
- PRINCIPAL INVESTIGATOR
Laura MacPherson, PhD
University of Maryland
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Laura MacPherson
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 13, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 18, 2022
Results First Posted
September 14, 2020
Record last verified: 2022-05