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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00737256
• Other study ID #: 07-0124
• Status: Recruiting
• Phase: Phase 2
• First received: August 14, 2008
• Last updated: September 6, 2012
• Start date: August 2008
• Est. completion date: May 2014

Study information

• Verified date: September 2012
• Source: Denver Research Institute
• Contact: Jennifer Ratzlaff, MA
• Phone: 303-399-8020
• Email: Jennifer.Ratzlaff[@]ucdenver.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00819689

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Schizophrenia

Intervention

Drug:
• Aripiprazole
15-30 mg
• Perphenazine
8-16 mg

Locations

Country	Name	City	State
United States	Veteran's Affairs Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Paul Saenger

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of negative urine drug screen results will be significantly greater in the subjects treated with aripiprazole than in those treated with perphenazine.		Week 3 and Week 8 of study participation	No
Secondary	The mean total self-report cocaine use days will be significantly fewer in subjects treated with aripiprazole than in those treated with perphenazine.		End of study participation	No
Secondary	The mean cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine.		End of study participation	No