Not Signed In -
Olanzapine Disintegrating Tablets |
Zyprexa Zydis Injection |
Clinical Trial: Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Risperidone and Olanzapine.
This study is currently recruiting patients.
Verified by Dartmouth-Hitchcock Medical Center September 2005
|
Purpose
| Condition | Intervention |
|---|---|
| Schizophrenia Dual Diagnosis Schizoaffective Disorder Psychotic Disorder Substance Abuse Cannabis Abuse | Drug: Clozapine Drug: Risperidone Drug: Olanzapine |
MedlinePlus related topics: Drug Abuse; Marijuana; Mental Health; Prescription Drug Abuse; Schizophrenia
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Cannabis and Schizophrenia: Effects of Clozapine
Secondary Outcomes: Clinical Symptoms will be measured weekly using the Brief Psychiatric Rating Scale and the Clinical Global Inventory. The Schedule for the Assessment of Negative Symptoms will be administered every other week. Suicidal thoughts will be assessed with the; Quality of life: Once a month we will use the Quality of Life scale scale developed by Heinrichs and the "subjective section" from the Quality of Life interview developed by Lehman.
Expected Total Enrollment: 100
Study start: March 2004
Between 13-42% of patients with schizophrenia or schizoaffective disorder have a cannabis use disorder during their lifetime. Cannabis use disorder in this population has been associated with clinical exacerbations, non-compliance with treatment, poor global functioning, and increased relapse and rehospitalization rates. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Retrospective data suggests that clozapine treatment was associated with a higher rate of remission from cannabis use (62-67%) compared to those treated with typical antipsychotics (32%) or risperidone (7.7%). We hypothesize that given its broad pharmacological profile clozapine treatment will be more effective than other antipsychotics, including risperidone and olanzapine, in controlling drug and alcohol use in persons with the dual disorders of schizophrenia and substance use disorders. The purpose of this study is to test the effectiveness of clozapine compared to risperidone and olanzapine in reducing cannabis and other substance use in this population.
One hundred subjects will be recruited from the participating sites. Persons age 18-65 of both genders and all racial groups are eligible. After a one-week baseline assessment period, subjects taking olanzapine and risperidone will be considered as two separate groups and randomized to stay on their current medication or to switch to clozapine. Clozapine will be prescribed by a research psychiatrist at an initial dose of 12.5mg and then increased, while the existing antipsychotic is tapered on an open label basis. If clinically tolerated, the dose of clozapine will be increased to 400 mg/day. Patients assigned to remain on olanzapine or risperidone will maintain their starting dose for the 12-week study. Although medication assignment will be known to prescribers and patients, all raters of symptoms and substance use will be blinded.
Eligibility
Inclusion Criteria:
- Schizophrenia or schizoaffective disorder (DSM IV).
- Cannabis Use Disorder, rated 3 or higher on the Drug Use Scale (Abuse or Dependence), and cannabis use on 5 days or more during the 3 weeks prior to assessment.
- Age 18-65.
- Taking olanzapine or risperidone (but not clozapine) for the past month.
- Second antipsychotic medications at low dose will be allowed as approved by the Medication Adjustment Group
- The participant (or the participant''''s authorized legal representative) understands the nature of the study and has he/she signed an informed consent.
- Recruited female subjects must agree to use a method of birth control approved by the study director for the duration of the study.
Exclusion Criteria:
- Contraindication to clozapine, risperidone or olanzapine treatment, including previous clozapine-induced granulocytopenia, mypoproliferative disorder, WBC < 3500/mm3, and history of seizures.
- Women who are currently pregnant or who desire to become pregnant during the course of the study.
- Current treatment with clozapine or second antipsychotic medication at doses higher than approved by Medication Adjustment Group, combinations of olanzapine and risperidone, or other psychotropic agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, inderol, tegretal, topiramate, and pramipexole).
- Participation in clinical trial of an investigational drug within 30 days of baseline visit, or concurrent participation in a treatment study of a psychosocial intervention.
- Inability to follow protocol requirements.
- Medical or legal problems such that the participant is likely to be jailed or in the hospital during much of their study participation.
- Developmental disability to the extent that the person could not participate in research interviews.
- Participant lives in a program to treat substance use disorders.
Location and Contact Information
New Hampshire
Mental Health Center of Greater Manchester, Manchester, New Hampshire, 03101, United States; Recruiting
Christopher O''''Keefe, MA 603-271-5747 christopher.okeefe@dartmouth.edu
West Central Behavioral Health, Lebanon, New Hampshire, 03766, United States; Recruiting
Christopher O''''Keefe, MA 603-271-5747 christopher.okeefe@dartmouth.edu
Riverbend, Concord, New Hampshire, 03301, United States; Recruiting
Christopher O''''Keefe, MA 603-271-5747 christopher.okeefe@dartmouth.edu
Institute for Clinical Research, Nashua, New Hampshire, 03060, United States; Recruiting
Christopher O''''Keefe, MA 603-271-5747 christopher.okeefe@dartmouth.edu
Alan I Green, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
More Information
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Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149955
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
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