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Alcoholism and Schizophrenia: Effects of Clozapine

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ClinicalTrials.gov Identifier: NCT00169026
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : March 14, 2018
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Harvard Medical School
Commonwealth Research Center, Massachusetts
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Dual Diagnosis Schizoaffective Disorder Psychotic Disorder Substance Abuse Alcohol Abuse Drug: Clozapine versus typical (conventional) and atypical antipsychotic medications Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Other
Official Title: Alcoholism and Schizophrenia: Effects of Clozapine
Study Start Date : May 1999
Estimated Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Clozapine
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169026

United States, Massachusetts
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Harvard Medical School
Commonwealth Research Center, Massachusetts
Principal Investigator: Alan I Green, MD Harvard Medical School

Responsible Party: Alan Green, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00169026     History of Changes
Other Study ID Numbers: AA11904
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by Alan Green, Dartmouth-Hitchcock Medical Center:
Atypical Antipsychotic
Conventional antipsychotic
Dual Diagnosis
Substance Abuse
Alcohol Abuse

Additional relevant MeSH terms:
Psychotic Disorders
Substance-Related Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Chemically-Induced Disorders
Alcohol-Related Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Antagonists
GABA Agents