Alcohol Abuse, Dual Diagnosis, Psychotic Disorder, Schizoaffective Disorder, Schizophrenia, Substance Abuse
Conditions
Keywords
Clozapine, Atypical Antipsychotic, Conventional antipsychotic, Schizophrenia, Dual Diagnosis, Substance Abuse, Alcohol Abuse
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.
Interventions
DRUGClozapine versus typical (conventional) and atypical antipsychotic medications
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Harvard Medical School (HMS and HSDM)
Commonwealth Research Center, Massachusetts
Novartis
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed