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Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01723163
First Posted: November 7, 2012
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: None (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 VA Office of Research and Development:

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 ]

Estimated Enrollment: 300
Actual Study Start Date: November 21, 2013
Estimated Study Completion Date: September 2017
Primary Completion Date: October 26, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723163


Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Patrick S Calhoun, PhD Durham VA Medical Center, Durham, NC
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01723163     History of Changes
Other Study ID Numbers: IIR 12-365
First Submitted: November 5, 2012
First Posted: November 7, 2012
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
veteran
smoking cessation