Recruiting
Phase 2

Aripiprazole

Sponsor:

Paul Saenger

Code:

NCT00737256

Conditions

Schizophrenia

Cocaine Dependence

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Aripiprazole

Perphenazine

Study Details

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.

Conditions

Schizophrenia

Cocaine Dependence

Study ID

NCT00737256

Start date

Aug, 2008

Status verified date

Sep, 2012

Completion date

May, 2014

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

active comparator: 2

Interventions

Aripiprazole

15-30 mg

Perphenazine

8-16 mg

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Veteran's Affairs Medical Center

Recruiting

Denver, Colorado, United States, 80220

Contacts

Lori Clapp, RN, MS

720-854-4200

More Information

Sponsor

Paul Saenger

Last update posted

Sep 7, 2012

Last verified

Sep, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul Saenger on 2012-09-07.