drugset / Trial / NCT00130923
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-09
- Primary completion
- 2009-06
- Completion
- 2010-07
Publications
- Background 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.
- Background 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.
- Background 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.
- Background Bartels SJ, Teague GB, Drake RE, Clark RE, Bush PW, Noordsy DL. Substance abuse in schizophrenia: service utilization and costs. J Nerv Ment Dis. 1993 Apr;181(4):227-32. doi: 10.1097/00005053-199304000-00003.
- Background Birkett MA, Day SJ. Internal pilot studies for estimating sample size. Stat Med. 1994 Dec 15-30;13(23-24):2455-63. doi: 10.1002/sim.4780132309.
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- Background 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.
- Background Buckley P, Thompson PA, Way L, Meltzer HY. Substance abuse and clozapine treatment. J Clin Psychiatry. 1994 Sep;55 Suppl B:114-6.
- Background 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.
- Background Buckley PF. Substance abuse in schizophrenia: a review. J Clin Psychiatry. 1998;59 Suppl 3:26-30.
- Background Buckley PF, Miller A, Chiles JA, Sajatovic M. Implementing effectiveness research and improving care for schizophrenia in real-world settings. Am J Manag Care. 1999 Jun 25;5 Spec No:SP47-56.
- Background 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.
- Background Coldham EL, Addington J, Addington D. Medication adherence of individuals with a first episode of psychosis. Acta Psychiatr Scand. 2002 Oct;106(4):286-90. doi: 10.1034/j.1600-0447.2002.02437.x.
- Background 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.
- Background Frison L, Pocock SJ. Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med. 1992 Sep 30;11(13):1685-704. doi: 10.1002/sim.4780111304.
- Background 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. doi: 10.3109/10673229909017206.
- Background 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. doi: 10.2174/1568007024606230.
- Background 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.
- Background Hunt GE, Bergen J, Bashir M. Medication compliance and comorbid substance abuse in schizophrenia: impact on community survival 4 years after a relapse. Schizophr Res. 2002 Apr 1;54(3):253-64. doi: 10.1016/s0920-9964(01)00261-4.
- Background Khantzian EJ. The self-medication hypothesis of addictive disorders: focus on heroin and cocaine dependence. Am J Psychiatry. 1985 Nov;142(11):1259-64. doi: 10.1176/ajp.142.11.1259.
- Background 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.
- Background 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.
- Background Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
- Background Lee, ET. Statistical Methods for Survival Analysis. 1992, New York: John Wiley & Sons.
- Background 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.
- Background 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.
- Background Siris SG. Pharmacological treatment of substance-abusing schizophrenic patients. Schizophr Bull. 1990;16(1):111-22. doi: 10.1093/schbul/16.1.111.
- Background 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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- Background Weiss RE, Lazaro CG. Residual plots for repeated measures. Stat Med. 1992 Jan 15;11(1):115-24. doi: 10.1002/sim.4780110110.
- Background 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.
- Green AI, Brunette MF, Dawson R, Buckley P, Wallace AE, Hafez H, Herz M, Narasimhan M, Noordsy DL, O'Keefe C, Sommi RW, Steinbook RM, Weeks M. Long-acting injectable vs oral risperidone for schizophrenia and co-occurring alcohol use disorder: a randomized trial. J Clin Psychiatry. 2015 Oct;76(10):1359-65. doi: 10.4088/JCP.13m08838.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 0.5 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 6 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 25 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 37.5 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 50 mg | Intramuscular |