Alcoholism and Schizophrenia: Effects of Clozapine
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ClinicalTrials.gov Identifier: NCT00169026
Recruitment Status :
First Posted : September 15, 2005
Last Update Posted : March 14, 2018
Dartmouth-Hitchcock Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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.
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 :
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.
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Ages Eligible for Study:
19 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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.