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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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 schizoaffective disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Janssen, LP
• Treatments: Ethanol; Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.