Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

October 24, 2018 updated by: VA Office of Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The addition of contingency management (CM) to existing evidenced-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is an intensive behavioral therapy that provides positive reinforcers (e.g., money, vouchers) to individuals misusing substances contingent upon objective evidence of abstinence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily with a clinic based carbon monoxide (CO) monitor. As a result, CM approaches have largely been relegated to inpatient and day treatment programs. The application of emerging smart-phone technology, however, can overcome this barrier. Investigators have developed a smart-phone application which allows a participant to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server. This innovation has made the use of CM for outpatient smoking cessation portable and feasible, i.e., mobile CM (mCM). Thus, the primary goal of the current study is to evaluate the effectiveness of a combined tele-health and 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.

Both of the proposed interventions are designed in accordance with national smoking cessation guidelines. Tele-health smoking cessation interventions are typically less intensive than clinic based specialty care, but increase reach of services through bypassing barriers to participation such as geographical distance from VA care. The addition of mCM to an evidence-based tele-health smoking intervention will significantly increase the intensity of the intervention and is predicted to increase efficacy. If cessation programs are to have significant impact (Impact = Reach X Efficacy) on changing health behavior at the population level, investigators must identify new and innovative strategies to increase treatment intensity, access, and participation.

The primary aim is to evaluate the impact of ART on rates of abstinence from cigarettes at 3-month, 6-month, and 12-month post-randomization follow-ups.

Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the ART-based intervention than those randomized to the Tele-health alone intervention (primary end-point; self-reported and bio-verified prolonged abstinence at the 6-month follow-up).

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center, Durham, NC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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 Names:
  • Intervention
Other: Control
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 Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
Time Frame: 6-month post-treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Patrick S Calhoun, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2013

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIR 12-365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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