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

Primary Purpose

Schizophrenia, Cocaine Dependence

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Perphenazine
Sponsored by
Paul Saenger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veteran's Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

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.

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

Full Information

First Posted
August 14, 2008
Last Updated
September 6, 2012
Sponsor
Paul Saenger
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1. Study Identification

Unique Protocol Identification Number
NCT00737256
Brief Title
A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
Official Title
A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Saenger

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
15-30 mg
Intervention Type
Drug
Intervention Name(s)
Perphenazine
Intervention Description
8-16 mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Ratzlaff, MA
Phone
303-399-8020
Ext
3855
Email
Jennifer.Ratzlaff@ucdenver.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Schmidt, MA
Phone
303-399-8020
Ext
2707
Email
Brandon.Schmidt@ucedenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas P Beresford, MD
Organizational Affiliation
Denver Veteran's Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veteran's Affairs Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Clapp, RN, MS
Phone
720-854-4200

12. IPD Sharing Statement

Learn more about this trial

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

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