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Aripiprazole for Co-Morbid Schizophrenia and Cocaine Dependence - NCT00819689-80220(Clinical Trial 262988)



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City:  Denver
State:  
CO
Zip Code: 80220
Conditions: Schizophrenia - Cocaine Dependence
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - Must have primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder - Must have DSM-IV diagnosis of current cocaine dependence - Self-report cocaine use in the last 90 days - Are capable of reading, comprehending and signing informed consent - Agree to take Aripiprazole or Perphenzine as treatment for SCHZ and CD - Agree to stop taking any other antipsychotic medication - If female and of child bearing potential, agree to use an acceptable form of birth control and have a negative pregnancy test within 2 days prior to starting study medication Exclusion Criteria: - Under 18 years old or over 65 years old - Refusal or inability to give informed consent - Have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension - A history of seizures or conditions that lower the seizure threshold - Have current suicidal ideation (history of suicide attempt in past 60 days) - Have current dependence, defined by DSM-IV criteria, on any psychoactive substance other than cocaine, alcohol, nicotine or marijuana, or psysiological dependence on alcohol requiring medical detoxification - Are actively psychotic which in the opinion of the investigator would preclude proper informed consenting or protocol adherence - Are receiving or plan to receive an agent metabolized by the Cytochrome P450-3A4 or -2D6 systems, including carbamazepine, ketoconizole, quinidine, fluoxetine, and paroxetine - Woman of child bearing potential not on, or do not agree to use an acceptable form of contraception - Known sensitivity to aripiprazole or perphenazine - A diagnosis of current of past tardive dyskensia - Pending legal charges or a court mandate for drug treatment - Currently taking concomitant medications that have been shown to reduce cocaine use. - Clinically significant liver function abnormalities - Currently receving depot neuroleptics
Study is available at: Department of Veterans Affairs Eastern Colorado Healthcare System
Denver, CO 80220
United States

Primary Contact:
Jennifer L Ratzlaff, M.A.
Email: jennifer.ratzlaff@uchsc.edu
Phone: 303-399-8020

Secondary Contact:
Jennifer L Ratzlaff, M.A.
Email: jennifer.ratzlaff@ucdenver.edu
Phone: 303-315-9103
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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