Alcoholism and Schizophrenia: Effects of Clozapine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2004-01-31

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.

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Detailed Description

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Conditions

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Schizophrenia Dual Diagnosis Schizoaffective Disorder Psychotic Disorder Substance Abuse Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Interventions

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Clozapine versus typical (conventional) and atypical antipsychotic medications

Intervention Type DRUG

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No