Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
2 other identifiers
interventional
133
1 country
1
Brief Summary
The goal of this research study is to examine the effects of a treatment for helping homeless veterans who smoke to stop smoking. Participants in the study will be assigned to one of two study groups. Participants in the first group will be referred to the local Department of Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group participants will receive a behavioral treatment designed to reward smokers for quitting and staying quit. These participants will also receive telephone counseling and medications for smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2014
Longer than P75 for phase_4
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
September 11, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2018
CompletedResults Posted
Study results publicly available
March 7, 2019
CompletedJanuary 4, 2022
December 1, 2021
3.5 years
September 11, 2014
February 6, 2019
December 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Self-reported and Bioverified Abstinent From Smoking
Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).
6 months
Secondary Outcomes (1)
Intervention Delivery Costs
6 months
Study Arms (2)
ART
EXPERIMENTALParticipants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.
Control Group
ACTIVE COMPARATORParticipants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Interventions
Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.
Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.
Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.
Eligibility Criteria
You may qualify if:
- Veteran
- Homeless
- Enrolled in Durham VA Medical Center for medical care
- Current smoker (at least 10 cigarettes per day)
- Willing to quit smoking in the next 30 days
You may not qualify if:
- Active substance dependence other than nicotine
- Uncontrolled psychotic symptoms
- Severely impaired hearing or speech (must be able to respond to telephone calls)
- Lack of interest in receiving telephone care
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela Kirby
- Organization
- Durham VA Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Jean C Beckham, PhD
Durham VA Medical Center, Durham, NC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2014
First Posted
September 19, 2014
Study Start
October 1, 2014
Primary Completion
March 30, 2018
Study Completion
September 28, 2018
Last Updated
January 4, 2022
Results First Posted
March 7, 2019
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share