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

NCT00737256 | Unknown Phase 2 DMC

• 1 other identifier: 07-0124
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• The mean cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine.

  End of study participation

Study Arms (2)

1

EXPERIMENTAL

Drug: Aripiprazole

2

ACTIVE COMPARATOR

Drug: Perphenazine

Interventions

Aripiprazole DRUG

15-30 mg

1

Perphenazine DRUG

8-16 mg

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Saenger: lead

Study Sites (1)

Veteran's Affairs Medical Center

Denver, Colorado, 80220, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Cocaine-Related Disorders

Interventions

Aripiprazole; Perphenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring

Study Officials

• Thomas P Beresford, MD

  Denver Veteran's Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Ratzlaff, MA

CONTACT

303-399-8020; Jennifer.Ratzlaff@ucdenver.edu

Brandon Schmidt, MA

CONTACT

303-399-8020; Brandon.Schmidt@ucedenver.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)