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NCT Number: NCT02161718

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

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

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Key information

Conditions

Schizophrenia Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alkermes Investigational Site, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samidorphan + olanzapine (ALKS 3831)

Drug

Oral tablet, taken once daily

Placebo + olanzapine

Drug

Oral tablet, taken once daily

Primary outcomes

  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):

    • Hospitalization (includes psychiatric& treatment of alcohol intoxication/withdrawal)
    • >= 25% or >= 15 point increase from randomization in PANSS total score
    • 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 outcomes

  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):

    • Hospitalization(includes psychiatric & treatment of alcohol intoxication/withdrawal)
    • >= 25% or >= 15 point increase from randomization in PANSS total score
    • 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

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2014
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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