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Partial Dopamine Agonist
1 for Schizophrenia
Phase 2
Waitlist Available
Led By Thomas P Beresford, MD
Research Sponsored by Paul Saenger
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study participation
Awards & highlights
Study 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.
Eligible Conditions
- Schizophrenia
- Cocaine Dependence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 3 and week 8 of study participation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3 and week 8 of study participation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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 cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine.
The mean total self-report cocaine use days will be significantly fewer in subjects treated with aripiprazole than in those treated with perphenazine.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Group II: 2Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aripiprazole
FDA approved
Find a Location
Who is running the clinical trial?
Paul SaengerLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Thomas P Beresford, MDPrincipal InvestigatorDenver Veteran's Affairs Medical Center
1 Previous Clinical Trials
50 Total Patients Enrolled
Frequently Asked Questions
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