Status:
COMPLETED
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Janssen, LP
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffect...
Detailed Description
Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managin...
Eligibility Criteria
Inclusion
- Ages 18-65
- Schizophrenia or schizoaffective disorder
- Meets the Structured Clinical Interview for DSM-IV (SCID) criteria for an alcohol use disorder
- Alcohol use on at least 5 days during the 4 weeks prior to randomization
- Patient is medically stable to start either form of risperidone.
Exclusion
- Current treatment with clozapine.
- Current treatment with injectable risperidone long-acting.
- Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
- Change in medications (dose of current medication, discontinuation of medication, or new medication) in past 30 days.
- History of or current breast cancer.
- History of intolerance of or allergy to risperidone or risperidone long-acting.
- Currently residing in a residential program designed to treat substance use disorders.
- Current treatment with long-acting, injectable antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
- Past treatment with risperidone long-acting will require a review by the medication adjustment group before entering the client into the study.
- Treatment at baseline with a second antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
- Treatment at baseline with a psychotropic agent proposed to curtail substance use will require a review by the medication adjustment group before entering the client into the study.
- Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00130923
Start Date
September 1 2005
End Date
July 1 2010
Last Update
May 9 2019
Active Locations (8)
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1
JMH Mental Health Center, University of Miami
Miami, Florida, United States, 33136
2
School of Pharmacy, Univ. of Missouri Kansas City
Kansas City, Missouri, United States, 64108
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
West Central Behavioral Health
Lebanon, New Hampshire, United States, 03766