Status:

TERMINATED

Alcoholism and Schizophrenia: Effects of Clozapine

Lead Sponsor:

Dartmouth-Hitchcock Medical Center

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Harvard Medical School (HMS and HSDM)

Conditions:

Schizophrenia

Dual Diagnosis

Eligibility:

All Genders

19-65 years

Phase:

PHASE4

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 great...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 1999

Trial Type :

INTERVENTIONAL

End Date :

January 1 2004

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT00169026

Start Date

May 1 1999

End Date

January 1 2004

Last Update

March 14 2018

Active Locations (1)

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1

Commonwealth Research Center

Jamaica Plain, Massachusetts, United States, 02130