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Sponsored by: |
University of Colorado at Denver and Health Sciences Center |
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Information provided by: | University of Colorado at Denver and Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT00819689 |
The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence (SCHZ+CD) subjects. Since aripiprazole has established effects against SCHZ, the study focuses on whether aripiprazole concurrently ameliorates co-morbid CD in SCHZ+CD sufferers compared to a standard typical antipsychotic treatment (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm of the study will yield fewer cocaine positive urine specimens as compared to the perphenazine control arm.
Condition | Intervention | Phase |
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Schizophrenia Cocaine Dependence |
Drug: Perphenazine Drug: Aripiprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence |
Estimated Enrollment: | 44 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Perphenazine as study medication
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Drug: Perphenazine
Starting dosage for double-blind medication Perphenazine will be 4 mg 3x per day for a total of 12 mg per 24 hours. Dosage adjustments, when necessary, will be conducted in 2 mg increments, with a maximum dosage of 24 mg per 24 hours.
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2: Active Comparator
Aripiprazole as study medication
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Drug: Aripiprazole
Starting dosage for double-blind medication Aripiprazole will begin at 15 mg per day, given in the morning. For consistency with the participants on perphenazine, placebos will be taken in the afternoon and evening. Dosage adjustments will be made in increments of 5 mg, with a minimum dose of 10 mg/day and a maximum of 30 mg/day.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer L Ratzlaff, M.A. | 303-399-8020 ext 3855 | jennifer.ratzlaff@uchsc.edu |
Contact: Emily L Andresen, Psy.D. | 720-854-4200 | emily.andresen@uchsc.edu |
United States, Colorado | |
Department of Veterans Affairs Eastern Colorado Healthcare System | Recruiting |
Denver, Colorado, United States, 80220 | |
Contact: Jennifer L Ratzlaff, M.A. 303-399-8020 ext 3855 jennifer.ratzlaff@uchsc.edu | |
Principal Investigator: Thomas P Beresford, M.D. |
Principal Investigator: | Thomas P Beresford, M.D. | University of Colorado Denver School of Medicine & Department of Veterans Affairs |
Responsible Party: | University of Colorado Denver School of Medicine ( Thomas P. Beresford, MD ) |
Study ID Numbers: | BMS Aripiprazole |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819689 |
Health Authority: | United States: Institutional Review Board |
schizophrenia cocaine dependence aripiprazole |
Cocaine-Related Disorders Schizophrenia Dopamine Perphenazine Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Psychotic Disorders Aripiprazole Cocaine Schizophrenia and Disorders with Psychotic Features |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Anesthetics Central Nervous System Depressants Dopamine Antagonists |
Cardiovascular Agents Antipsychotic Agents Pharmacologic Actions Anesthetics, Local Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |