Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders

June 25, 2015 updated by: US Department of Veterans Affairs

Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses

This study examines the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses who want to quit smoking. We hypothesize that participants randomized to receive contingent rewards for group attendance will attend more treatment sessions than those in the control group.

Study Overview

Detailed Description

Schizophrenia and other psychotic disorders are highly prevalent in the VA population and are associated with high rates of smoking. Although smoking cessations approaches that work for non-schizophrenic patients such as behavioral counseling and medications appear to be efficacious for schizophrenic smokers, a major obstacle in providing adequate treatment is poor attendance at treatment sessions. Contingency management has been shown to shape treatment behavior in non-schizophrenic smokers and to shape other behaviors such as cocaine use and exercise in schizophrenics.

The intention of this project is to examine the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses and to compare two different approaches to providing contingent incentives in this context. Subjects in the experimental condition draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Subjects in the experimental condition receive a set reward that will not change regardless of attendance at consecutive sessions. We hypothesize that the participants in the experimental condition will attend more smoking cessation group therapy sessions than those in the control condition because they will have the possibility, although not the likelihood, to obtain contingent reinforcement of greater value.

Study Type

Interventional

Enrollment (Actual)

23

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

    • Washington
      • Seattle, Washington, United States, 98109
        • VA Puget Sound Health Care System

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:

  • All subjects must be diagnosed with schizophrenia or any other psychotic disorder, bipolar disorder with psychotic features, or major depression with psychotic features according to the electronic medical record.
  • Current nicotine use, defined as smoking 5 or more cigarettes/day for at least 16 of the past 30 days prior to study screening.
  • Prospective subjects must indicate willingness to attend smoking cessation group therapy.

Exclusion Criteria:

  • Imminent risk for suicide or violence.
  • Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions).
  • Clinically apparent, gross cognitive impairment.

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: Arm 1
Experimental
Participants draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Tokens include messages of encouragement ("Good job!") or VA canteen vouchers of varying monetary value.
Active Comparator: Arm 2
Active Comparator
Participants receive set reward (VA canteen voucher) for each week of smoking cessation treatment they attend. The value of the reward will not change regardless of attendance at consecutive sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of treatment sessions attended
Time Frame: 11 weeks
11 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in cigarettes per day
Time Frame: 3 and 6 months
3 and 6 months
7- and 30-day point prevalence abstinence
Time Frame: 3 and 6 months
3 and 6 months
Continuous abstinence from quit date
Time Frame: 3 and 6 months
3 and 6 months
Days to relapse from quit date
Time Frame: Up to 6 months
Up to 6 months
Change in BPRS scores
Time Frame: 3 and 6 months
3 and 6 months
Change in PHQ-9 scores
Time Frame: 3 and 6 months
3 and 6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Andrew J. Saxon, MD, VA Puget Sound Health Care System

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

July 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 27, 2007

First Submitted That Met QC Criteria

July 27, 2007

First Posted (Estimate)

July 30, 2007

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

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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