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

NCT ID: NCT00737256

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

15-30 mg

2

Group Type ACTIVE_COMPARATOR

Perphenazine

Intervention Type DRUG

8-16 mg

Interventions

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Aripiprazole

15-30 mg

Intervention Type DRUG

Perphenazine

8-16 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul Saenger

OTHER

Sponsor Role lead

Responsible Party

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Paul Saenger

Executive Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas P Beresford, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Veteran's Affairs Medical Center

Locations

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Veteran's Affairs Medical Center

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Ratzlaff, MA

Role: CONTACT

Phone: 303-399-8020

Email: [email protected]

Brandon Schmidt, MA

Role: CONTACT

Phone: 303-399-8020

Email: [email protected]

Facility Contacts

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Lori Clapp, RN, MS

Role: primary

Other Identifiers

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07-0124

Identifier Type: -

Identifier Source: org_study_id

NCT00819689

Identifier Type: -

Identifier Source: nct_alias