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Clinical Trial: Risperidone Long-Acting Vs. Oral Risperidone in Patients with Schizophrenia and Alcohol Use Disorder.
This study is not yet open for patient recruitment.
Verified by Dartmouth-Hitchcock Medical Center August 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia Schizoaffective Disorder Psychotic Disorder Substance Abuse Alcohol Abuse | Drug: risperidone long-acting (drug) Drug: oral risperidone (drug) | Phase IV |
MedlinePlus related topics: Alcoholism; Drug Abuse; Mental Health; Prescription Drug Abuse; Schizophrenia
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)
Secondary Outcomes: Other substance use as assessed by the Timeline Followback scale.; Also: Clinical symptoms,global functioning, cognition, and extrapyramidal system effects.
Expected Total Enrollment: 80
Expected completion: December 2007
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. After screening, patients will be randomize
Eligibility
Inclusion Criteria:
- Age 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.
Location and Contact Information
Marjorie HW Weeks, MPA 603-271-5747 marjorie.h.w.weeks@dartmouth.edu
Florida
JMH Mental Health Center, University of Miami, Miami, Florida, 33136, United States
Marvin Herz, MD 305-868-6286 mherz@med.miami.edu
Marvin Herz, MD, Principal Investigator
Missouri
School of Pharmacy, Univ. of Missouri Kansas City, Kansas City, Missouri, 64108, United States
Joan Hunter, RN, CCRC 816-512-7476 hunterjr@umkc.edu
Roger W. Sommi, Pharm D, Principal Investigator
Washington University School of Medicine, St. Louis, Missouri, 63110, United States
Emily Thomason 314-286-1620 emily@conte.wustl.edu
Devna Rastogi-Cruz, MD, Principal Investigator
New Hampshire
Greater Manchester Mental Health Center, Manchester, New Hampshire, 03101, United States
Margaret AE Almeida, RN, BC, MBA 603-668-4111 Ext. 5301 almeidam@mhcgm.org
Mary F. Brunette, MD, Principal Investigator
South Carolina
University of South Carolina, Columbia, South Carolina, 29203, United States
Frank Ballard, MA 803-434-1100 fballard@gw.mp.sc.edu
Meera Narasimhan, MD, Principal Investigator
Vermont
White River Junction Veterans Admininistration Medical Center, White River Junction, Vermont, 05009, United States
Linda Kinney, MPA 802-295-9363 Ext. 6284 linda.kinney@med.va.gov
Amy E. Wallace, MD, Principal Investigator
Alan I. Green, MD, Principal Investigator, Dartmouth Medical School, Dartmouth College
More Information
Publications
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Bowers MB Jr, Mazure CM, Nelson JC, Jatlow PI. Psychotogenic drug use and neuroleptic response. Schizophr Bull. 1990;16(1):81-5.
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.
Buckley P, Thompson PA, Way L, Meltzer HY. Substance abuse and clozapine treatment. J Clin Psychiatry. 1994 Sep;55 Suppl B:114-6.
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Green AI, Zimmet SV, Strous RD, Schildkraut JJ. Clozapine for comorbid substance use disorder and schizophrenia: do patients with schizophrenia have a reward-deficiency syndrome that can be ameliorated by clozapine? Harv Rev Psychiatry. 1999 Mar-Apr;6(6):287-96. Review.
Green AI, Salomon MS, Brenner MJ, Rawlins K. Treatment of schizophrenia and comorbid substance use disorder. Curr Drug Targets CNS Neurol Disord. 2002 Apr;1(2):129-39. Review.
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.
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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. Review.
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. Review.
Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
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.
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.
Siris SG. Pharmacological treatment of substance-abusing schizophrenic patients. Schizophr Bull. 1990;16(1):111-22. Review.
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.
Weiss RE, Lazaro CG. Residual plots for repeated measures. Stat Med. 1992 Jan 15;11(1):115-24.
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.
Last Updated: August 15, 2005
Record first received: August 15, 2005
ClinicalTrials.gov Identifier: NCT00130923
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23
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