- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00508560
Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders
Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- VA Puget Sound Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Andrew J. Saxon, MD, VA Puget Sound Health Care System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUD-Q
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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