Clinical trial NCT00508560: Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders
Official title: Contingency Management for Smoking Cessation Among Veterans With Schizophrenia or Other Psychoses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nicotine Dependence
Psychotic Disorders
Keywords: Contingency management
Smoking cessation
Psychotic disorders
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-07-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Number of treatment sessions attended
timeFrame: 11 weeks
Secondary outcomes:
measure: Reduction in cigarettes per day
timeFrame: 3 and 6 months
measure: 7- and 30-day point prevalence abstinence
timeFrame: 3 and 6 months
measure: Continuous abstinence from quit date
timeFrame: 3 and 6 months
measure: Days to relapse from quit date
timeFrame: Up to 6 months
measure: Change in BPRS scores
timeFrame: 3 and 6 months
measure: Change in PHQ-9 scores
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Andrew J. Saxon, MD
role: PRINCIPAL_INVESTIGATOR
References: