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

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00130923
First received: August 15, 2005
Last updated: September 23, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Schizophrenia
Psychotic Disorders
Substance Abuse
Alcohol Abuse
Drug: Risperidone Long Acting
Drug: oral risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Mean Heavy Drinking Days Per Week [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other Substance Use as Assessed by the Timeline Followback Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 95
Study Start Date: September 2005
Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130923

Locations
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
St. 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
Investigators
Principal Investigator: Alan I. Green, MD Dartmouth Medical School, Dartmouth College
  More Information

Publications:
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.

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00130923     History of Changes
Other Study ID Numbers: 17359, RIS-EMR-4032
Study First Received: August 15, 2005
Results First Received: July 23, 2012
Last Updated: September 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Risperidone
Schizophrenia
Substance Use Disorder
Alcohol Use Disorder
Treatment
Schizoaffective Disorder

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Alcoholism
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Alcohol-Related Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 22, 2014