Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Nicotine Dependence; Psychotic Disorders	Behavioral: Contingency Management; Behavioral: Reward	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	23 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses
Study Start Date :	July 2007
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Number of treatment sessions attended [ Time Frame: 11 weeks ]

Secondary Outcome Measures :

1. Reduction in cigarettes per day [ Time Frame: 3 and 6 months ]
2. 7- and 30-day point prevalence abstinence [ Time Frame: 3 and 6 months ]
3. Continuous abstinence from quit date [ Time Frame: 3 and 6 months ]
4. Days to relapse from quit date [ Time Frame: Up to 6 months ]
5. Change in BPRS scores [ Time Frame: 3 and 6 months ]
6. Change in PHQ-9 scores [ Time Frame: 3 and 6 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00508560 History of Changes
Other Study ID Numbers:	SUD-Q
First Posted:	July 30, 2007
Last Update Posted:	June 26, 2015
Last Verified:	June 2015

Keywords provided by VA Office of Research and Development:

Contingency management; Smoking cessation; Psychotic disorders; Veterans

Additional relevant MeSH terms:

Mental Disorders; Psychotic Disorders; Tobacco Use Disorder	Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders; Chemically-Induced Disorders