Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

Study Overview
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Brief Summary
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There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.

Detailed Description
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There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.

Official Title
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Incentives Plus Bupropion for Smoking in Schizophrenics

Conditions
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Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder

Intervention / Treatment
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* Drug: Bupropion
* Drug: Contingent reinforcement plus placebo
* Drug: non-contingent reinforcement plus bupropion
* Drug: Non-contingent reinforcement plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications Exclusion Criteria: Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Contingent reinforcement plus bupropion | Drug: Bupropion<br>* Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)<br>* Other names: zyban, wellbutrin;|
| Experimental: 2<br>Contingent reinforcement plus placebo | Drug: Contingent reinforcement plus placebo<br>* contingent reinforcement plus placebo (3 weeks)<br>|
| Experimental: 3<br>Non-contingent reinforcement plus bupropion | Drug: non-contingent reinforcement plus bupropion<br>* non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)<br>* Other names: zyban, wellbutrin;|
| Placebo Comparator: 4<br>Non-contingent reinforcement plus placebo | Drug: Non-contingent reinforcement plus placebo<br>* Non-contingent reinforcement plus placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Cotinine | Urinary Cotinine levels at Week 4 (average of last 3 study visits) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes Smoked Per Day |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco