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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130923
Recruitment Status : Completed
First Posted : August 16, 2005
Results First Posted : October 24, 2012
Last Update Posted : March 23, 2018
Janssen, LP
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

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 schizoaffective disorder.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Substance Abuse Alcohol Abuse Drug: Risperidone Long Acting Drug: oral risperidone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)
Study Start Date : September 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: Risperidone Long Acting
Risperidone Long Acting; aka Risperdal Consta; injectable form
Drug: Risperidone Long Acting
Dose 25.00, 37.50 or 50.00 mg q two weeks
Other Name: Risperdal Consta

Active Comparator: Oral Risperidone
Oral Risperidone; aka Risperdal; oral form
Drug: oral risperidone
0.50-6.00 mg oral risperidone daily
Other Name: Risperdal

Primary Outcome Measures :
  1. Mean Heavy Drinking Days Per Week [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Other Substance Use as Assessed by the Timeline Followback Scale [ Time Frame: 6 months ]
  2. Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130923

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United States, Florida
JMH Mental Health Center, University of Miami
Miami, Florida, United States, 33136
United States, Missouri
School of Pharmacy, Univ. of Missouri Kansas City
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
West Central Behavioral Health
Lebanon, New Hampshire, United States, 03766
Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States, 03101
Center for Psychiatric Advancement
Nashua, New Hampshire, United States, 03060
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29203
United States, Vermont
White River Junction Veterans Admininistration Medical Center
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Janssen, LP
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Principal Investigator: Alan I. Green, MD Dartmouth Medical School, Dartmouth College

Albanese M. Risperidone in substance abusers with bipolar disorder. Presented at the 39th Annual Meeting of the American College of Neuropsychopharmacology. Sa Juan, PR, 2000.
Akaike, H, Information theory and an extension of the maximum likelihood principle., in 2nd International Symposium on Information Theory and Control., EBN Petrovand & C. Csaki, Editors. 1973, Akademia Kiado: Budapest, p. 267-281.
Buckley P, McCarthy M, Chapman P, Richman C, Yamamoto B. Clozapine treatment of comorbid substance abuse in patients with schizophrenia. Schizophr Res 1999, 36:272.
Lee, ET. Statistical Methods for Survival Analysis. 1992, New York: John Wiley & Sons.
Tukey, JW. Exploratory Data Analysis. 1977, Reading, MA: Addison Wesley Publ. Co.
Waternaux, C, Laird, N, Ware, J. Methods for the analysis of longitudinal data: Blood concentrations and cognitive development. J.Amer. Stat. Assoc. 1989: 84, p.33-41.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alan Green, Principal Investigator, Dartmouth-Hitchcock Medical Center Identifier: NCT00130923     History of Changes
Other Study ID Numbers: 17359
First Posted: August 16, 2005    Key Record Dates
Results First Posted: October 24, 2012
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Alan Green, Dartmouth-Hitchcock Medical Center:
Substance Use Disorder
Alcohol Use Disorder
Schizoaffective Disorder

Additional relevant MeSH terms:
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Substance-Related Disorders
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Chemically-Induced Disorders
Alcohol-Related Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents