NCT00130923|CompletedPhase 4ResultsDMC
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)
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Sponsor study identifier
Secondary identifiers
interventional
95
1 country
8
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
July 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 15, 2005
Actual (reported)August 16, 2005
Actual (reported)September 2005
Date type not reportedThis date has not been verified as actual or estimated.
June 2009
Actual (reported)July 2010
Actual (reported)October 24, 2012
Actual (reported)Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy)
Frequency of heavy drinking days is obtained each week retrospectively as the number of heavy drinking days during the prior week (assessed by the Timeline Followback Scale). A heavy drinking day is defined as 4 or more drinks per day for a female and 5 or more drinks per day for a male. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
6 months
Average Over Time of Frequency of Drinking Days (Used to Evaluate Treatment Efficacy)
6 months
Risperidone Long Acting; aka Risperdal Consta; injectable form
Oral Risperidone; aka Risperdal; oral form
Dose 25.00, 37.50 or 50.00 mg q two weeks
JMH Mental Health Center, University of Miami
Miami, Florida, 33136, United States
School of Pharmacy, Univ. of Missouri Kansas City
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
West Central Behavioral Health
Lebanon, New Hampshire, 03766, United States
Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03101, United States
Center for Psychiatric Advancement
Nashua, New Hampshire, 03060, United States
University of South Carolina
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.
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.
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Alan I. Green, MD
Dartmouth Medical School, Dartmouth College
95 participants (actual enrollment reported by the registry).
First Submitted
August 15, 2005
First Posted
August 16, 2005
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Average Over Time of Severity of Illness and Global Improvement (Used to Evaluate Treatment Efficacy)
6 months
Average Over Time of Positive and Negative Symptoms (Used to Evaluate Treatment Efficacy)
6 months
Average Over Time of Global Functioning (Used to Evaluate Treatment Efficacy)
6 months
Number of Participants With Medication Adherence
6 months
Contact the study team to confirm eligibility.
Columbia, South Carolina, 29203, United States
White River Junction Veterans Admininistration Medical Center
White River Junction, Vermont, 05009, United States
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.
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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.
Buckley P, Thompson PA, Way L, Meltzer HY. Substance abuse and clozapine treatment. J Clin Psychiatry. 1994 Sep;55 Suppl B:114-6.
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.
Buckley PF. Substance abuse in schizophrenia: a review. J Clin Psychiatry. 1998;59 Suppl 3:26-30.
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.
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.
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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, 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.
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.
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.
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.
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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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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.
Primary Completion
June 2009
Actual (reported)Study Completion
July 2010
Actual (reported)Last Updated
May 9, 2019
Results First Posted
October 24, 2012
Record last verified: 2019-04
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