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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Dartmouth-Hitchcock Medical Center University of Missouri, Kansas City VA Medical Center-West Los Angeles University of South Carolina |
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00498550 |
Many individuals with schizophrenia also suffer from marijuana addiction. Clozapine, an atypical antipsychotic medication, may prove useful at preventing drug relapse in schizophrenic individuals who are seeking treatment for marijuana addiction. The purpose of this study is to compare the effectiveness of clozapine, vs. treatment-as-usual with other oral antipsychotics at reducing marijuana use in schizophrenic individuals.
Condition | Intervention | Phase |
Schizophrenia Dual Diagnosis Schizoaffective Disorder Psychotic Disorder Cannabis Abuse |
Drug: Clozapine Drug: Treatment as usual |
Phase IV |
MedlinePlus related topics: | Dual Diagnosis Psychotic Disorders Schizophrenia |
ChemIDplus related topics: | Clozapine Cannabis GW-1000 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Cannabis and Schizophrenia: Effects of Clozapine |
Estimated Enrollment: | 35 |
Study Start Date: | October 2000 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Clozapine: Experimental
Clozapine, Clozaril
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Drug: Clozapine
Clozapine up to 550mg qd
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Treatment as usual: Active Comparator
Treatment as usual with any antipsychotic other than Clozapine.
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Drug: Treatment as usual
Remain on pre-study antipsychotic treatment
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Individuals with schizophrenia have a high risk of becoming addicted to drugs; between 13 to 42% of schizophrenics are addicted to marijuana. These individuals often have difficulties adhering to a substance abuse treatment program, and have an increased chance of marijuana relapse. Marijuana use by schizophrenics has also been associated with clinical exacerbations, noncompliance with antipsychotic medications, poor global functioning, and increased rehospitalization rates. While antipsychotic medications are often effective in controlling symptoms of schizophrenia, they are not always effective in preventing substance abuse. Clozapine, an atypical antipsychotic drug, is currently used to treat schizophrenia. Preliminary research has shown that clozapine is more successful at reducing drug relapse rates in individuals with schizophrenia, as compared to other antipsychotic medications, including olanzapine and risperidone. The purpose of this study is to compare the effectiveness of clozapine as compared to other oral antipsychotic treatment, including combinations of up to two antipsychotics, in reducing marijuana use in schizophrenic individuals.
This study will enroll individuals with schizophrenia who are currently taking any oral antipsychotic other than clozapine, including those taking up to two oral antipsychotic, and who are also addicted to marijuana. The study will begin with a 1-week assessment phase, during which all participants will continue taking olanzapine or risperidone. Participants will undergo a physical examination and have blood drawn for laboratory tests. Information pertaining to their medical, psychiatric, and substance use history will also be collected. Urine tests and breathalyzers will be used to screen for the presence of alcohol and drugs. Following the assessment phase, participants will be randomly assigned to switch to clozapine or remain on their prestudy antipsychotic for 12 weeks. Participants remaining on their prestudy antipsychotic treatment will continue to receive the same dose for the entire study. Participants taking clozapine will initially receive a daily dose of 12.5 mg, which will be increased to a maximum of 400 mg per day, as tolerated. Study visits will take place once a week. At each visit, medication side effects, physical and psychological symptoms, substance use, treatment services received, and living situation will be assessed. Blood will be drawn for laboratory tests. Drug and alcohol levels will be monitored three times a week through urine and breathalyzer tests. Quality of life questionnaires will be administered once a month.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher O'Keefe, MA | 603-271-5287 | Christopher.Okeefe@dartmouth.edu |
United States, California | |||||
West LA VAHCS | Recruiting | ||||
Los Angeles, California, United States, 90073 | |||||
Contact: Lisa Guzik, BA 310-478-3711 ext 44187 lisa.guzik@va.gov | |||||
Contact: Danielle Goldstein, BA 310-478-3711 ext 49853 dg@ucla.edu | |||||
United States, Missouri | |||||
University Missouri | Recruiting | ||||
Kansas City, Missouri, United States, 64108 | |||||
Contact: Joan Hunter, BSN 816-512-7476 hunterjr@umkc.edu | |||||
United States, New Hampshire | |||||
Mental Health Center of Greater Manchester | Recruiting | ||||
Manchester, New Hampshire, United States, 03101 | |||||
Contact: Margaret Almeida, RN, BC, MBA 603-668-4111 ext 5301 almeidam@mhcgm.org | |||||
United States, South Carolina | |||||
University South Carolina | Recruiting | ||||
Columbia, South Carolina, United States, 29203 | |||||
Contact: Travis Bruce, MD 803-434-1642 tbruce@gw.mp.sc.edu |
National Institute on Drug Abuse (NIDA) |
Dartmouth-Hitchcock Medical Center |
University of Missouri, Kansas City |
VA Medical Center-West Los Angeles |
University of South Carolina |
Principal Investigator: | Alan Green, MD | Dartmouth-Hitchcock Medical Center |
Responsible Party: | Dartmouth Medical School ( Alan I. Green, MD ) |
Study ID Numbers: | NCT00149955 |
First Received: | July 6, 2007 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00498550 |
Health Authority: | United States: Federal Government |
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