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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Denver Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Paul Saenger, Denver Research Institute
ClinicalTrials.gov Identifier:
NCT00737256
First received: August 14, 2008
Last updated: September 6, 2012
Last verified: September 2012
  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 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 Intervention Phase
Schizophrenia
Cocaine Dependence
Drug: Aripiprazole
Drug: Perphenazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Denver Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: August 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Aripiprazole
15-30 mg
Active Comparator: 2 Drug: Perphenazine
8-16 mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737256

Contacts
Contact: Jennifer Ratzlaff, MA 303-399-8020 ext 3855 Jennifer.Ratzlaff@ucdenver.edu
Contact: Brandon Schmidt, MA 303-399-8020 ext 2707 Brandon.Schmidt@ucedenver.edu

Locations
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
Investigators
Principal Investigator: Thomas P Beresford, MD Denver Veteran's Affairs Medical Center
  More Information

No publications provided

Responsible Party: Paul Saenger, Executive Director, Denver Research Institute
ClinicalTrials.gov Identifier: NCT00737256     History of Changes
Obsolete Identifiers: NCT00819689
Other Study ID Numbers: 07-0124
Study First Received: August 14, 2008
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cocaine-Related Disorders
Schizophrenia
Chemically-Induced Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Substance-Related Disorders
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014