Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01723163
First received: November 5, 2012
Last updated: September 26, 2014
Last verified: September 2014
  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:


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: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723163

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
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: September 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
veteran
smoking cessation

ClinicalTrials.gov processed this record on November 20, 2014