We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

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.
ClinicalTrials.gov Identifier: NCT01723163
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 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 or disease Intervention/treatment
Veteran Smoking Cessation Behavioral: Abstinence Reinforcement Therapy (ART) Behavioral: Telephone Counseling and NRT

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
Actual Study Start Date : November 21, 2013
Primary Completion Date : December 15, 2016
Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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).

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

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01723163     History of Changes
Other Study ID Numbers: IIR 12-365
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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