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Tracking Information | |||||
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First Received Date † | August 15, 2005 | ||||
Last Updated Date | March 4, 2009 | ||||
Start Date † | September 2005 | ||||
Current Primary Outcome Measures † |
Alcohol use assessed by the Timeline Followback scale [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00130923 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Risperidone Long-Acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder | ||||
Official Title † | Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST) | ||||
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. |
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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 Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 100 | ||||
Estimated Completion Date | June 2010 | ||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00130923 | ||||
Responsible Party | Alan I. Green, MD, Dartmouth Medical School | ||||
Secondary IDs †† | RIS-EMR-4032 | ||||
Study Sponsor † | Dartmouth-Hitchcock Medical Center | ||||
Collaborators †† | Janssen, LP | ||||
Investigators † |
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Information Provided By | Dartmouth-Hitchcock Medical Center | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |