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A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02161718
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).

Condition or disease Intervention/treatment Phase
Schizophrenia Alcohol Use Disorder Drug: Samidorphan + olanzapine (ALKS 3831) Drug: Placebo + olanzapine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder
Actual Study Start Date : May 2014
Actual Primary Completion Date : January 11, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Samidorphan + olanzapine (ALKS 3831)
Active study drug
Drug: Samidorphan + olanzapine (ALKS 3831)
Oral tablet, taken once daily

Placebo Comparator: Placebo + olanzapine Drug: Placebo + olanzapine
Oral tablet, taken once daily

Primary Outcome Measures :
  1. Time to first event of exacerbation of disease [ Time Frame: Up to 15 months ]

Secondary Outcome Measures :
  1. Percentage of subjects with adverse events (AEs) [ Time Frame: Up to 16 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has a BMI between 18.0 and 40.0 kg/m2, inclusive
  • Has a diagnosis of schizophrenia
  • Has a diagnosis of alcohol use disorder (AUD)
  • Has experienced an acute exacerbation of schizophrenia within the past 6 months
  • Additional criteria may apply

Exclusion Criteria:

  • Is pregnant or breastfeeding
  • Had first lifetime psychotic episode less than 1 year before screening or has experienced only a single lifetime psychotic episode
  • Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
  • Has current or pending legal charges with the potential for incarceration
  • Has a positive drug screen for opiates
  • Additional criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02161718

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Sponsors and Collaborators
Alkermes, Inc.
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Study Director: David McDonnell, MD Alkermes, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alkermes, Inc. Identifier: NCT02161718    
Other Study ID Numbers: ALK3831-401
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Keywords provided by Alkermes, Inc.:
Alcohol Use Disorder
ALKS 3831
Additional relevant MeSH terms:
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Alcohol Drinking
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents