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A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737256
Recruitment Status : Unknown
Verified September 2012 by Paul Saenger, Denver Research Institute.
Recruitment status was:  Recruiting
First Posted : August 18, 2008
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Paul Saenger, Denver Research Institute

Brief Summary:
The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. Since aripiprazole has established effects against schizophrenia, the study focuses on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm of the study will give fewer cocaine positive urine specimens as compared to the perphenazine control arm.

Condition or disease Intervention/treatment Phase
Schizophrenia Cocaine Dependence Drug: Aripiprazole Drug: Perphenazine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
Study Start Date : August 2008
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 1 Drug: Aripiprazole
15-30 mg

Active Comparator: 2 Drug: Perphenazine
8-16 mg

Primary Outcome Measures :
  1. The proportion of negative urine drug screen results will be significantly greater in the subjects treated with aripiprazole than in those treated with perphenazine. [ Time Frame: Week 3 and Week 8 of study participation ]

Secondary Outcome Measures :
  1. The mean total self-report cocaine use days will be significantly fewer in subjects treated with aripiprazole than in those treated with perphenazine. [ Time Frame: End of study participation ]
  2. The mean cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine. [ Time Frame: End of study participation ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder
  2. Have a DSM-IV diagnosis of current cocaine dependence.
  3. Are capable of reading, comprehending, and signing informed consent.
  4. Agree to take Aripiprazole or Perphenazine as treatment for SCHZ and CD.
  5. Agree to stop taking any other antipsychotic medication
  6. If female and of child bearing potential (WOCBP) 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:

  1. Under 18 years old or over 65 years old.
  2. Refusal or inability to give informed consent,
  3. Have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension (dehydration, hypovolemia),
  4. A history of seizures or conditions that lower the seizure threshold
  5. Have current suicidal ideation (history of suicide attempt in past 60 days)
  6. Are actively psychotic which in the opinion of the investigator would preclude proper informed consenting or protocol adherence
  7. Are receiving or plan to receive an agent metabolized by the Cytochrome P450-3A4 or -2D6 systems, including carbamazepine, ketoconazole, quinidine, fluoxetine, and paroxetine
  8. WOCBP not on, or do not agree to use an acceptable form of contraception
  9. Known sensitivity to aripiprazole or perphenazine
  10. A diagnosis of current or past tardive dyskinesia
  11. Pending legal charges or a court mandate for drug treatment
  12. Currently taking concomitant medications that have been shown to reduce cocaine use, such as disulfiram
  13. Clinically significant liver function abnormalities
  14. Currently receiving depot neuroleptics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737256

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Contact: Jennifer Ratzlaff, MA 303-399-8020 ext 3855
Contact: Brandon Schmidt, MA 303-399-8020 ext 2707

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United States, Colorado
Veteran's Affairs Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Lori Clapp, RN, MS    720-854-4200      
Sponsors and Collaborators
Paul Saenger
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Principal Investigator: Thomas P Beresford, MD Denver Veteran's Affairs Medical Center
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Responsible Party: Paul Saenger, Executive Director, Denver Research Institute Identifier: NCT00737256    
Obsolete Identifiers: NCT00819689
Other Study ID Numbers: 07-0124
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists