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Aripiprazole for Co-Morbid Schizophrenia and Cocaine Dependence
This study is currently recruiting participants.
Verified by University of Colorado at Denver and Health Sciences Center, January 2009
Sponsored by: University of Colorado at Denver and Health Sciences Center
Information provided by: University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier: NCT00819689
  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.


Condition Intervention Phase
Schizophrenia
Cocaine Dependence
Drug: Perphenazine
Drug: Aripiprazole
Phase III

MedlinePlus related topics: Schizophrenia Urine and Urination
Drug Information available for: Perphenazine Perphenazine enanthate Aripiprazole 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride
U.S. FDA Resources
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

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Primary Outcome Measures:
  • Number of cocaine-positive urine samples [ Time Frame: 3x weekly through 8 week medication trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and severity of cocaine cravings as measured by the Brief Substance Craving Scale and the Clinical Global Impression Scale (Observer and Self-Report versions) [ Time Frame: weekly throughout 8 week medication trial ] [ Designated as safety issue: No ]

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
1: Active Comparator
Perphenazine as study medication
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.
2: Active Comparator
Aripiprazole as study medication
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819689

Contacts
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

Locations
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.            
Sponsors and Collaborators
University of Colorado at Denver and Health Sciences Center
Investigators
Principal Investigator: Thomas P Beresford, M.D. University of Colorado Denver School of Medicine & Department of Veterans Affairs
  More Information

Publications:
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

Keywords provided by University of Colorado at Denver and Health Sciences Center:
schizophrenia
cocaine dependence
aripiprazole

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009