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| Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Janssen, LP |
|---|---|
| Information provided by: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00130923 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST) |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Risperidone Long Acting
|
Drug: risperidone long-acting
Dose 25.00, 37.50 or 50.00 mg q two weeks
|
|
2: Active Comparator
Oral Risperidone aka Risperdal
|
Drug: oral risperidone
0.50-6.00 mg oral risperidone qd
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher D. O'Keefe, MA | 603-271-5747 | christopher.d.o'keefe@dartmouth.edu |
| Contact: Marjorie HW Weeks, MPA | 603-271-5747 | marjorie.h.w.weeks@dartmouth.edu |
| United States, Florida | |
| JMH Mental Health Center, University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Richard Steinbook, MD 305-355-8260 rsteinbook@med.miami.edu | |
| Contact: Marvin Herz, MD 305-868-6286 mherz@med.miami.edu | |
| Principal Investigator: Marvin Herz, MD | |
| United States, Missouri | |
| School of Pharmacy, Univ. of Missouri Kansas City | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Roger W. Sommi, Pharm D 816-512-7475 sommi@umkc.edu | |
| Contact: Joan Hunter, RN, CCRC 816-512-7476 hunterjr@umkc.edu | |
| Principal Investigator: Roger W. Sommi, Pharm D | |
| Washington University School of Medicine | Active, not recruiting |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Hampshire | |
| Mental Health Center of Greater Manchester | Recruiting |
| Manchester, New Hampshire, United States, 03101 | |
| Contact: Mary F. Brunette, MD 603-668-4111 ext 5301 mary.f.brunette@dartmouth.edu | |
| Contact: Margaret AE Almeida, RN, BC, MBA 603-668-4111 ext 5301 almeidam@mhcgm.org | |
| Principal Investigator: Mary F. Brunette, MD | |
| West Central Behavioral Health | Recruiting |
| Lebanon, New Hampshire, United States, 03766 | |
| Contact: Doug Noordsy, MD 603-448-5610 | |
| Contact: Kari Barton 603-448-5610 Kari.A.Barton@Hitchcock.ORG | |
| Principal Investigator: Doug Noordsy, MD | |
| Center for Psychiatric Advancement | Recruiting |
| Nashua, New Hampshire, United States, 03060 | |
| Contact: Hisham Hafez, MD 603-889-6147 | |
| Contact: Diane Scotina (603) 889-6147 scotinad@ccofnashua.org | |
| Principal Investigator: Hisham Hafez, MD | |
| United States, South Carolina | |
| University of South Carolina | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Meera Narasimhan, MD 803-434-6089 mnarasim@gw.mp.sc.edu | |
| Contact: Frank Ballard, MA 803-434-1100 fballard@gw.mp.sc.edu | |
| Principal Investigator: Meera Narasimhan, MD | |
| United States, Vermont | |
| White River Junction Veterans Admininistration Medical Center | Recruiting |
| White River Junction, Vermont, United States, 05009 | |
| Contact: Amy E. Wallace, MD 802-295-9363 ext 5673 aew@dartmouth.edu | |
| Contact: Linda Kinney, MPA 802-295-9363 ext 6284 linda.kinney@med.va.gov | |
| Principal Investigator: Amy E. Wallace, MD | |
| Principal Investigator: | Alan I. Green, MD | Dartmouth Medical School, Dartmouth College |
More Information
| Responsible Party: | Dartmouth Medical School ( Alan I. Green, MD ) |
| Study ID Numbers: | 17359, RIS-EMR-4032 |
| Study First Received: | August 15, 2005 |
| Last Updated: | June 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00130923 |
| Health Authority: | United States: Institutional Review Board |
|
Risperidone Schizophrenia Substance Use Disorder |
Alcohol Use Disorder Treatment Schizoaffective Disorder |
|
Risperidone Disorders of Environmental Origin Alcohol Drinking Serotonin Schizophrenia Dopamine Mental Disorders |
Alcoholism Substance-Related Disorders Psychotic Disorders Alcohol-Related Disorders Schizophrenia and Disorders with Psychotic Features Ethanol |
|
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |
