Clinical trial NCT00169026: Alcoholism and Schizophrenia: Effects of Clozapine
Official title: Alcoholism and Schizophrenia: Effects of Clozapine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Dual Diagnosis
Schizoaffective Disorder
Psychotic Disorder
Substance Abuse
Alcohol Abuse
Keywords: Clozapine
Atypical Antipsychotic
Conventional antipsychotic
Schizophrenia
Dual Diagnosis
Substance Abuse
Alcohol Abuse
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Harvard Medical School (HMS and HSDM)
name: Commonwealth Research Center, Massachusetts
name: Novartis
First posted: 2005-09-15
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Jamaica Plain
country: United States
facility: Commonwealth Research Center
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Alan I Green, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.