Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders

This study has been terminated.
(Stopped due to low recruitment.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00508560
First received: July 27, 2007
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Nicotine Dependence
Psychotic Disorders
Behavioral: Contingency Management
Behavioral: Reward

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Number of treatment sessions attended [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in cigarettes per day [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • 7- and 30-day point prevalence abstinence [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Continuous abstinence from quit date [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Days to relapse from quit date [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Change in BPRS scores [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in PHQ-9 scores [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: July 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Experimental
Behavioral: Contingency Management
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
Behavioral: Reward
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00508560

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Investigators
Principal Investigator: Andrew J. Saxon, MD VA Puget Sound Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00508560     History of Changes
Other Study ID Numbers: SUD-Q
Study First Received: July 27, 2007
Last Updated: December 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Contingency management
Smoking cessation
Psychotic disorders
Veterans

Additional relevant MeSH terms:
Tobacco Use Disorder
Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 14, 2014