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Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

This study is not yet open for participant recruitment.
Verified April 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01723163
First received: November 5, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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 300 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.


Condition Intervention
Veteran
Smoking Cessation
 Behavioral: Abstinence Reinforcement Therapy (ART)
Behavioral: Telephone Counseling and NRT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Primary outcome measure will be quality-adjusted life years (QALYs). The QALY is a standardized effectiveness measure that allows for the comparison of the value of a particular intervention to a broad range of other potential health care investments [ Time Frame: 12 month post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Abstinence Reinforcement Therapy (ART)
 Behavioral: Abstinence Reinforcement Therapy (ART)
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)
Other Name: Intervention
Arm 2
Telephone Counseling
 Behavioral: Telephone Counseling and NRT
Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
Other Name: Control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723163

Contacts
Contact: Lauren Hair lauren.hair@va.gov
Contact: Patrick S Calhoun, PhD (919) 286-6936 patrick.calhoun2@va.gov

Locations
United States, North Carolina
Durham VA Medical Center Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Dana C Tucker     919-286-0411 ext 5741     dana.tucker@va.gov    
Contact: Susan B Armstrong     (919) 286-6936     beth.armstrong@va.gov    
Sub-Investigator: Jean C Beckham, PhD            
Sub-Investigator: Jennifer M Gierisch, BS MPH PhD            
Sub-Investigator: Maren K. Olsen, PhD            
Sub-Investigator: Matthew L. Maciejewski, PhD            
Principal Investigator: Patrick S. Calhoun, PhD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Patrick S. Calhoun, PhD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01723163     History of Changes
Other Study ID Numbers: IIR 12-365
Study First Received: November 5, 2012
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
veteran
smoking cessation

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on June 18, 2013