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
Information provided by (Responsible Party):
Paul Saenger, Denver Research Institute
First received: August 14, 2008
Last updated: September 6, 2012
Last verified: September 2012
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Active Comparator: 2
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder
- Have a DSM-IV diagnosis of current cocaine dependence.
- 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 (WOCBP) agree to use an acceptable form of birth control and have a negative pregnancy test within 2 days prior to starting study medication
- 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 (dehydration, hypovolemia),
- A history of seizures or conditions that lower the seizure threshold
- Have current suicidal ideation (history of suicide attempt in past 60 days)
- 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
- WOCBP not on, or do not agree to use an acceptable form of contraception
- Known sensitivity to aripiprazole or perphenazine
- A diagnosis of current or 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, such as disulfiram
- Clinically significant liver function abnormalities
- Currently receiving depot neuroleptics
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
|Veteran's Affairs Medical Center
|Denver, Colorado, United States, 80220 |
|Contact: Lori Clapp, RN, MS 720-854-4200 |
||Thomas P Beresford, MD
||Denver Veteran's Affairs Medical Center
No publications provided
||Paul Saenger, Executive Director, Denver Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 14, 2008
||September 6, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Agents
Central Nervous System Depressants
Physiological Effects of Drugs