Smoking Cessation Clinical Trial
Official title:
Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
Verified date | October 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal of the current study is to evaluate the effectiveness of a combined
tele-health and contingency management (CM) intervention that investigators are calling
Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a
two-group design in which 310 Veteran smokers will be randomized to either:
ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines
guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for
access to nicotine replacement (NRT), and intensive behavioral therapy through mobile
contingency management.
TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide
controls for therapist, medication, time and attention effects. The tele-health intervention
provides the same guideline based cognitive-behavioral smoking cessation telephone counseling
(TC), and tele-medicine clinic for access to NRT as in the ART intervention.
Status | Completed |
Enrollment | 310 |
Est. completion date | September 2017 |
Est. primary completion date | December 15, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Enrolled in the Durham VA for ongoing care. - Current smokers planning to quit smoking in the next 30 days. Exclusion Criteria: - Active diagnosis of psychosis documented in the medical record. - Does not have access to a telephone. - Severely impaired hearing or speech (Veterans must be able to respond to phone calls). |
Country | Name | City | State |
---|---|---|---|
United States | Durham VA Medical Center, Durham, NC | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Calhoun PS, Wilson SM, Hertzberg JS, Kirby AC, McDonald SD, Dennis PA, Bastian LA, Dedert EA; VA Mid-Atlantic MIRECC Workgroup, Beckham JC. Validation of Veterans Affairs Electronic Medical Record Smoking Data Among Iraq- and Afghanistan-Era Veterans. J G — View Citation
Dennis PA, Kimbrel NA, Dedert EA, Beckham JC, Dennis MF, Calhoun PS. Supplemental nicotine preloading for smoking cessation in posttraumatic stress disorder: Results from a randomized controlled trial. Addict Behav. 2016 Aug;59:24-9. doi: 10.1016/j.addbeh — View Citation
Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Tröster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pai — View Citation
Wilson SM, Hair LP, Hertzberg JS, Kirby AC, Olsen MK, Lindquist JH, Maciejewski ML, Beckham JC, Calhoun PS. Abstinence Reinforcement Therapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention. Contemp Clin Trials. 2016 Sep — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up. | 6-month post-treatment |
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