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

Sponsor:	Denver Research Institute
Information provided by:	Denver Research Institute
ClinicalTrials.gov Identifier:	NCT00737256

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Cocaine Dependence	Drug: Aripiprazole Drug: Perphenazine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia Urine and Urination

Drug Information available for: Perphenazine Perphenazine enanthate Aripiprazole

U.S. FDA Resources

Further study details as provided by Denver Research Institute:

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:	44
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Aripiprazole 15-30 mg
Active Comparator: 2	Drug: Perphenazine 8-16 mg

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737256

Contacts

Contact: Lori Clapp, RN, MS	720-854-4200	lori.clapp@uchsc.edu
Contact: Lindsey Varvil-Weld, BA	720-854-4200	lindsey.varvil-weld@uchsc.edu

Locations

United States, Colorado
Veteran's Affairs Medical Center	Recruiting
Denver, Colorado, United States, 80220
Contact: Lori Clapp, RN, MS 720-854-4200

Sponsors and Collaborators

Denver Research Institute

Investigators

Principal Investigator:

Thomas P Beresford, MD

Denver Veteran's Affairs Medical Center

More Information

No publications provided

Responsible Party:	Thomas P. Beresford, MD, Denver Veteran's Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00737256 History of Changes
Other Study ID Numbers:	07-0124
Study First Received:	August 14, 2008
Last Updated:	August 14, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Schizophrenia
Cocaine-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Substance-Related Disorders
Perphenazine
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012