Alcoholism and Schizophrenia: Effects of Clozapine

This study has been terminated.
Sponsor:
Collaborators:
Harvard Medical School
Commonwealth Research Center, Massachusetts
Novartis
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00169026
First received: September 10, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Alcoholism and Schizophrenia: Effects of Clozapine

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 64
Study Start Date: May 1999
Estimated Study Completion Date: January 2004
  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169026

Locations
United States, Massachusetts
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Harvard Medical School
Commonwealth Research Center, Massachusetts
Novartis
Investigators
Principal Investigator: Alan I Green, MD Harvard Medical School
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00169026     History of Changes
Other Study ID Numbers: AA11904
Study First Received: September 10, 2005
Last Updated: September 10, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:
Clozapine
Atypical Antipsychotic
Conventional antipsychotic
Schizophrenia
Dual Diagnosis
Substance Abuse
Alcohol Abuse

Additional relevant MeSH terms:
Alcoholism
Psychotic Disorders
Mental Disorders
Schizophrenia
Substance-Related Disorders
Alcohol-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Clozapine
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on July 22, 2014