Alcoholism and Schizophrenia: Effects of Clozapine

Study Overview
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Brief Summary
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The purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications.

Official Title
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Alcoholism and Schizophrenia: Effects of Clozapine

Conditions
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Schizophrenia, Dual Diagnosis, Schizoaffective Disorder, Psychotic Disorder, Substance Abuse, Alcohol Abuse

Intervention / Treatment
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* Drug: Clozapine versus typical (conventional) and atypical antipsychotic medications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Current diagnosis of an alcohol use disorder with active use in the last 30 days. The participant (or the participant's authorized legal representative) understands the nature of the study and has he/she signed an informed consent. Ages 19-65. Taking olanzapine, risperidone, quetiapine or a typical antipsychotic agent for at least 8 weeks prior to study randomization If taking depot medication, at least 3 injection cycles since the last injection prior to study randomization. Exclusion Criteria: Contraindication to clozapine Women who are currently pregnant or who desire to become pregnant during the course of the study. Current and past treatment with clozapine Current treatment with agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, buspirone) and agents contraindicated for use with clozapine (e.g., inderal, tegretol, lithium). Meets DSM-IV criteria for current dependence of substances other than alcohol.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clozapine versus typical (conventional) and atypical antipsychotic medications|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Measures: Brief Psychiatric Rating Scale; Scale for the Assessment of Negative Symptoms; and Clinical Global Impression; neurological side affects, cognitive assessment and quality of life measure. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clozapine, Atypical Antipsychotic, Conventional antipsychotic, Schizophrenia, Dual Diagnosis, Substance Abuse, Alcohol Abuse