Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
1 other identifier
interventional
310
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
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
November 5, 2012
CompletedFirst Posted
Study publicly available on registry
November 7, 2012
CompletedStudy Start
First participant enrolled
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
March 1, 2019
CompletedMarch 1, 2019
October 1, 2018
3.1 years
November 5, 2012
December 14, 2017
October 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Intervention
EXPERIMENTALAbstinence Reinforcement Therapy (ART)
Control
OTHERTelephone Counseling
Interventions
Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
Eligibility Criteria
You may qualify if:
- Enrolled in the Durham VA for ongoing care.
- Current smokers planning to quit smoking in the next 30 days.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
Related Publications (4)
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;50:157-65. doi: 10.1016/j.cct.2016.08.008. Epub 2016 Aug 10.
PMID: 27521811RESULTDennis 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.2016.03.004. Epub 2016 Mar 11.
PMID: 27046670RESULTGreen KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.
PMID: 28340108RESULTCalhoun 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 Gen Intern Med. 2017 Nov;32(11):1228-1234. doi: 10.1007/s11606-017-4144-5. Epub 2017 Aug 14.
PMID: 28808856RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Patrick Calhoun
- Organization
- Durham Veterans Affairs Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick S Calhoun, PhD
Durham VA Medical Center, Durham, NC
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2012
First Posted
November 7, 2012
Study Start
November 21, 2013
Primary Completion
December 15, 2016
Study Completion
September 1, 2017
Last Updated
March 1, 2019
Results First Posted
March 1, 2019
Record last verified: 2018-10