Back to resultsAlcoholism and Schizophrenia: Effects of Clozapine
Primary Purpose
Schizophrenia, Dual Diagnosis, Schizoaffective Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clozapine versus typical (conventional) and atypical antipsychotic medications
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Clozapine, Atypical Antipsychotic, Conventional antipsychotic, Schizophrenia, Dual Diagnosis, Substance Abuse, Alcohol Abuse
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.
Sites / Locations
- Commonwealth Research Center
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
Full Information
NCT ID
NCT00169026
First Posted
September 10, 2005
Last Updated
March 12, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Harvard Medical School (HMS and HSDM), Commonwealth Research Center, Massachusetts, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00169026
Brief Title
Alcoholism and Schizophrenia: Effects of Clozapine
Official Title
Alcoholism and Schizophrenia: Effects of Clozapine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Harvard Medical School (HMS and HSDM), Commonwealth Research Center, Massachusetts, Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Dual Diagnosis, Schizoaffective Disorder, Psychotic Disorder, Substance Abuse, Alcohol Abuse
Keywords
Clozapine, Atypical Antipsychotic, Conventional antipsychotic, Schizophrenia, Dual Diagnosis, Substance Abuse, Alcohol Abuse
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Clozapine versus typical (conventional) and atypical antipsychotic medications
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan I Green, MD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth Research Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10370435
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.
Results Reference
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Alcoholism and Schizophrenia: Effects of Clozapine
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