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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00169026
Other study ID # AA11904
Secondary ID
Status Terminated
Phase Phase 4
First received September 10, 2005
Last updated March 12, 2018
Start date May 1999
Est. completion date January 2004

Study information

Verified date March 2018
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 64
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
Clozapine versus typical (conventional) and atypical antipsychotic medications


Locations

Country Name City State
United States Commonwealth Research Center Jamaica Plain Massachusetts

Sponsors (5)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Commonwealth Research Center, Massachusetts, Harvard Medical School, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Novartis

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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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