Alcoholism and Schizophrenia: Effects of Clozapine

Schizophrenia Clinical Trial

Official title:

Alcoholism and Schizophrenia: Effects of Clozapine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00169026
• Other study ID #: AA11904
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Disease
• Dual Diagnosis
• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Substance Abuse
• Substance-Related Disorders

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.