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

Information source: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Psychotic Disorders; Substance Abuse; Alcohol Abuse

Intervention: Risperidone Long Acting (Drug); oral risperidone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Dartmouth-Hitchcock Medical Center

Official(s) and/or principal investigator(s):
Alan I. Green, MD, Principal Investigator, Affiliation: Dartmouth Medical School, Dartmouth College

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.

Clinical Details

Official title: Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Heavy Drinking Days Per Week

Secondary outcome:

Other Substance Use as Assessed by the Timeline Followback Scale

Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects

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 managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects. In addition, medication non-compliance is common among patients with schizophrenia. Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia. A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders. Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents, improving negative symptoms and ameliorating a dysfunction of the brain reward system. Risperidone long-acting injectable medication addresses issues of noncompliance, while avoiding peak blood levels of oral preparations, thereby minimizing EPS and improving negative symptoms of schizophrenia. Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system. This study is an open, randomized, controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use. Patients with schizophrenia or schizoaffective disorder, age 18 to 65, who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

JMH Mental Health Center, University of Miami, Miami, Florida 33136, United States

School of Pharmacy, Univ. of Missouri Kansas City, Kansas City, Missouri 64108, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

West Central Behavioral Health, Lebanon, New Hampshire 03766, United States

Mental Health Center of Greater Manchester, Manchester, New Hampshire 03101, United States

Center for Psychiatric Advancement, Nashua, New Hampshire 03060, United States

University of South Carolina, Columbia, South Carolina 29203, United States

White River Junction Veterans Admininistration Medical Center, White River Junction, Vermont 05009, United States

Additional Information

Related publications:

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Starting date: September 2005
Last updated: August 3, 2015

Page last updated: August 23, 2015

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