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Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00130923
First received: August 15, 2005
Last updated: September 23, 2012
Last verified: September 2012

August 15, 2005
September 23, 2012
September 2005
June 2009   (final data collection date for primary outcome measure)
Mean Heavy Drinking Days Per Week [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Alcohol use assessed by the Timeline Followback scale.
Complete list of historical versions of study NCT00130923 on ClinicalTrials.gov Archive Site
  • Other Substance Use as Assessed by the Timeline Followback Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Other substance use as assessed by the Timeline Followback scale.
  • Also: Clinical symptoms,global functioning, cognition, and extrapyramidal system effects.
Not Provided
Not Provided
 
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
  • Substance Abuse
  • Alcohol Abuse
  • Drug: Risperidone Long Acting
    Dose 25.00, 37.50 or 50.00 mg q two weeks
    Other Name: Risperdal Consta
  • Drug: oral risperidone
    0.50-6.00 mg oral risperidone daily
    Other Name: Risperdal
  • Experimental: Risperidone Long Acting
    Risperidone Long Acting; aka Risperdal Consta; injectable form
    Intervention: Drug: Risperidone Long Acting
  • Active Comparator: Oral Risperidone
    Oral Risperidone; aka Risperdal; oral form
    Intervention: Drug: oral risperidone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
July 2010
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00130923
17359, RIS-EMR-4032
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Janssen, LP
Principal Investigator: Alan I. Green, MD Dartmouth Medical School, Dartmouth College
Dartmouth-Hitchcock Medical Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP