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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.
 
ClinicalTrials.gov Identifier: NCT02161718
Recruitment Status : Completed
First Posted : June 12, 2014
Results First Posted : October 8, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) [ Time Frame: Up to 15 months ]

    EEDS was defined as any of the following occurring during the double-blind period & was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):

    1. Hospitalization (includes psychiatric& treatment of alcohol intoxication/withdrawal)
    2. >= 25% or >= 15 point increase from randomization in PANSS total score
    3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:

    3a. Score >= 5 for subjects at a 2nd ad hoc visit with a score <=3 at randomization 3b. Score >= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease



Secondary Outcome Measures :
  1. Number of Events of Exacerbation of Disease (EEDS) [ Time Frame: Up to 15 months ]

    EEDS was defined as any of the following occurring during the double-blind period & was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC):

    1. Hospitalization(includes psychiatric & treatment of alcohol intoxication/withdrawal)
    2. >= 25% or >= 15 point increase from randomization in PANSS total score
    3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following:

    3a. Score >= 5 for subjects at a 2nd ad hoc visit with a score <=3 at randomization 3b. Score >= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease


  2. Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) [ Time Frame: 24 weeks ]

    Alcohol consumption per day = (total number of drinks x 14 gram) / (total number of days)

    WHO criteria for risk of alcohol consumption on a single drinking day:

    Abstinence- Males: 0 g; Females- 0 g Low Risk- Males: 1-40 g; Females: 1-20 g Medium Risk- Males: 41- 60 g; Females: 21- 40 g High Risk- Males: 61-100 g; Females: 41-60 g Very High Risk- Males: >= 101 g; Females: >= 61 g



Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02161718


Locations
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Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: David McDonnell, MD Alkermes, Inc.
  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:
Study Protocol  [PDF] March 1, 2016
Statistical Analysis Plan  [PDF] January 20, 2017

More Information
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Publications of Results:

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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02161718    
Other Study ID Numbers: ALK3831-401
First Posted: June 12, 2014    Key Record Dates
Results First Posted: October 8, 2021
Last Update Posted: October 8, 2021
Last Verified: September 2021
Keywords provided by Alkermes, Inc.:
Alkermes
Schizophrenia
Alcohol Use Disorder
ALKS 3831
Additional relevant MeSH terms:
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Disease
Alcoholism
Schizophrenia
Alcohol Drinking
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Olanzapine
Antiemetics
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