Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder

Completed · Phase 4

Conditions studied: Schizophrenia, Psychotic Disorders, Substance Abuse, Alcohol Abuse

In brief

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 schizoaffective disorder.

Key facts

Study ID

NCT00130923

Run by

Dartmouth-Hitchcock Medical Center

People needed

95

Starts

2005-09-01

Expected to finish

2010-07-01

Last updated by the study team

2019-05-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• JMH Mental Health Center, University of Miami — Miami, Florida, United States
• School of Pharmacy, Univ. of Missouri Kansas City — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• West Central Behavioral Health — Lebanon, New Hampshire, United States
• Mental Health Center of Greater Manchester — Manchester, New Hampshire, United States
• Center for Psychiatric Advancement — Nashua, New Hampshire, United States
• University of South Carolina — Columbia, South Carolina, United States
• White River Junction Veterans Admininistration Medical Center — White River Junction, Vermont, United States

Full record on ClinicalTrials.gov

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