Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
NCT ID: NCT00130923
Last Updated: 2019-05-09
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
95 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-09-30
Study Completion Date
2010-07-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Schizophrenia
Psychotic Disorders
Substance Abuse
Alcohol Abuse
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Risperidone Long Acting
Risperidone Long Acting; aka Risperdal Consta; injectable form
Group Type
EXPERIMENTAL
Risperidone Long Acting
Intervention Type
DRUG
Dose 25.00, 37.50 or 50.00 mg q two weeks
Oral Risperidone
Oral Risperidone; aka Risperdal; oral form
Group Type
ACTIVE_COMPARATOR
oral risperidone
Intervention Type
DRUG
0.50-6.00 mg oral risperidone daily
Interventions
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Risperidone Long Acting
Dose 25.00, 37.50 or 50.00 mg q two weeks
Intervention Type
DRUG
oral risperidone
0.50-6.00 mg oral risperidone daily
Intervention Type
DRUG
Other Intervention Names
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Risperdal Consta
Risperdal
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Janssen, LP
INDUSTRY
Sponsor Role
collaborator
Dartmouth-Hitchcock Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Alan Green
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Alan I. Green, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth Medical School, Dartmouth College
Locations
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JMH Mental Health Center, University of Miami
Miami, Florida, United States
Site Status
School of Pharmacy, Univ. of Missouri Kansas City
Kansas City, Missouri, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
West Central Behavioral Health
Lebanon, New Hampshire, United States
Site Status
Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States
Site Status
Center for Psychiatric Advancement
Nashua, New Hampshire, United States
Site Status
University of South Carolina
Columbia, South Carolina, United States
Site Status
White River Junction Veterans Admininistration Medical Center
White River Junction, Vermont, United States
Site Status
Countries
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United States
References
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Albanese MJ, Khantzian EJ, Murphy SL, Green AI. Decreased substance use in chronically psychotic patients treated with clozapine. Am J Psychiatry. 1994 May;151(5):780-1. doi: 10.1176/ajp.151.5.780b. No abstract available.
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Buckley P, Thompson P, Way L, Meltzer HY. Substance abuse among patients with treatment-resistant schizophrenia: characteristics and implications for clozapine therapy. Am J Psychiatry. 1994 Mar;151(3):385-9. doi: 10.1176/ajp.151.3.385.
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Buckley PF. Novel antipsychotic medications and the treatment of comorbid substance abuse in schizophrenia. J Subst Abuse Treat. 1998 Mar-Apr;15(2):113-6. doi: 10.1016/s0740-5472(97)00134-7.
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Drake RE, Xie H, McHugo GJ, Green AI. The effects of clozapine on alcohol and drug use disorders among patients with schizophrenia. Schizophr Bull. 2000;26(2):441-9. doi: 10.1093/oxfordjournals.schbul.a033464.
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Green AI, Burgess ES, Dawson R, Zimmet SV, Strous RD. Alcohol and cannabis use in schizophrenia: effects of clozapine vs. risperidone. Schizophr Res. 2003 Mar 1;60(1):81-5. doi: 10.1016/s0920-9964(02)00231-1.
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Khantzian EJ. The self-medication hypothesis of substance use disorders: a reconsideration and recent applications. Harv Rev Psychiatry. 1997 Jan-Feb;4(5):231-44. doi: 10.3109/10673229709030550.
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Lacro JP, Dunn LB, Dolder CR, Leckband SG, Jeste DV. Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: a comprehensive review of recent literature. J Clin Psychiatry. 2002 Oct;63(10):892-909. doi: 10.4088/jcp.v63n1007.
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Lee, ET. Statistical Methods for Survival Analysis. 1992, New York: John Wiley & Sons.
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Newton TF, Ling W, Kalechstein AD, Uslaner J, Tervo K. Risperidone pre-treatment reduces the euphoric effects of experimentally administered cocaine. Psychiatry Res. 2001 Jul 24;102(3):227-33. doi: 10.1016/s0165-1781(01)00255-4.
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Salyers MP, Mueser KT. Social functioning, psychopathology, and medication side effects in relation to substance use and abuse in schizophrenia. Schizophr Res. 2001 Mar 1;48(1):109-23. doi: 10.1016/s0920-9964(00)00063-3.
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Smelson DA, Losonczy MF, Davis CW, Kaune M, Williams J, Ziedonis D. Risperidone decreases craving and relapses in individuals with schizophrenia and cocaine dependence. Can J Psychiatry. 2002 Sep;47(7):671-5. doi: 10.1177/070674370204700710.
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Zimmet SV, Strous RD, Burgess ES, Kohnstamm S, Green AI. Effects of clozapine on substance use in patients with schizophrenia and schizoaffective disorder: a retrospective survey. J Clin Psychopharmacol. 2000 Feb;20(1):94-8. doi: 10.1097/00004714-200002000-00016.
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Reference Type
DERIVED
Other Identifiers
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RIS-EMR-4032
Identifier Type: -
Identifier Source: secondary_id
17359
Identifier Type: -
Identifier Source: org_study_id
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