NCT00169026

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started May 1999

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

First QC Date

September 10, 2005

Last Update Submit

March 12, 2018

Conditions

SchizophreniaDual DiagnosisSchizoaffective DisorderPsychotic DisorderSubstance AbuseAlcohol Abuse

Keywords

ClozapineAtypical AntipsychoticConventional antipsychoticSchizophreniaDual DiagnosisSubstance AbuseAlcohol Abuse

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Clozapine versus typical (conventional) and atypical antipsychotic medicationsDRUG

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Commonwealth Research Center

Jamaica Plain, Massachusetts, 02130, United States

Location

Related Publications (1)

  • Green AI, Zimmet SV, Strous RD, Schildkraut JJ. Clozapine for comorbid substance use disorder and schizophrenia: do patients with schizophrenia have a reward-deficiency syndrome that can be ameliorated by clozapine? Harv Rev Psychiatry. 1999 Mar-Apr;6(6):287-96. doi: 10.3109/10673229909017206.

    PMID: 10370435BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSubstance-Related DisordersAlcoholism

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced DisordersAlcohol-Related Disorders

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Alan I Green, MD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

May 1, 1999

Study Completion

January 1, 2004

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

US(1)