Aripiprazole for Co-Morbid Schizophrenia and Cocaine Dependence
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | October 2008 |
| End Date: | December 2012 |
| Contact: | Jennifer L Ratzlaff, M.A. |
| Email: | jennifer.ratzlaff@ucdenver.edu |
| Phone: | 303-399-8020 |
A Double-Blind, Controlled Study of Aripiprazole Versus Perphenazine in Co-Morbid Schizophrenia and Cocaine Dependence
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.
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 perphenazine 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 physiological 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, ketoconazole, 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 dyskinesia
- 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 receiving depot neuroleptics
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