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

NCT02161718 | Completed Phase 2 Results

• 1 other identifier: ALK3831-401
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 71

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).

Conditions

Schizophrenia; Alcohol Use Disorder

Keywords

Alkermes; Schizophrenia; Alcohol Use Disorder; ALKS 3831

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)

  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

  Up to 15 months

Secondary Outcomes (2)

• Number of Events of Exacerbation of Disease (EEDS)

  Up to 15 months

• 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)

  24 weeks

Study Arms (2)

Samidorphan + olanzapine (ALKS 3831)

EXPERIMENTAL

Active study drug

Drug: Samidorphan + olanzapine (ALKS 3831)

Placebo + olanzapine

PLACEBO COMPARATOR

Drug: Placebo + olanzapine

Interventions

Samidorphan + olanzapine (ALKS 3831) DRUG

Oral tablet, taken once daily

Samidorphan + olanzapine (ALKS 3831)

Placebo + olanzapine DRUG

Oral tablet, taken once daily

Placebo + olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (71)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Springdale, Arkansas, 72764, United States

Location

Alkermes Investigational Site

Anaheim, California, 92805, United States

Location

Alkermes Investigational Site

Culver City, California, 90230, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

Irvine, California, 92617, United States

Location

Alkermes Investigational Site

La Jolla, California, 92037, United States

Location

Alkermes Investigational Site

Long Beach, California, 90822, United States

Location

Alkermes Investigational Site

National City, California, 91950, United States

Location

Alkermes Investigational Site

Oakland, California, 94612, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

San Diego, California, 92123, United States

Location

Alkermes Investigational Site

San Francisco, California, 94121, United States

Location

Alkermes Investigational Site

Torrance, California, 90502, United States

Location

Alkermes Investigational Site

Washington D.C., District of Columbia, 20016, United States

Location

Alkermes Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

Alkermes Investigational Site

Leesburg, Florida, 34748, United States

Location

Alkermes Investigational Site

Maitland, Florida, 32751, United States

Location

Alkermes Investigational Site

Miami, Florida, 33122, United States

Location

Alkermes Investigational Site

Miami, Florida, 33136, United States

Location

Alkermes Investigational Site

North Miami, Florida, 33021, United States

Location

Alkermes Investigational Site

Oakland Park, Florida, 33334, United States

Location

Alkermes Investigational Site

Orlando, Florida, 32803, United States

Location

Alkermes Investigational Site

Tampa, Florida, 33613, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30308, United States

Location

Alkermes Investigational Site

Augusta, Georgia, 30912, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Alkermes Investigational Site

Oak Brook, Illinois, 60523, United States

Location

Alkermes Investigational Site

Shreveport, Louisiana, 71101, United States

Location

Alkermes Investigational Site

Worcester, Massachusetts, 01605, United States

Location

Alkermes Investigational Site

Flowood, Mississippi, 39232, United States

Location

Alkermes Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Alkermes Investigational Site

Kansas City, Missouri, 64108, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63118, United States

Location

Alkermes Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Alkermes Investigational Site

Claremont, New Hampshire, 03743, United States

Location

Alkermes Investigational Site

Nashua, New Hampshire, 03060, United States

Location

Alkermes Investigational Site

Neptune City, New Jersey, 07753, United States

Location

Alkermes Investigational Site

Cedarhurst, New York, 11516, United States

Location

Alkermes Investigational Site

Jamaica, New York, 11423, United States

Location

Alkermes Investigational Site

New York, New York, 10021, United States

Location

Alkermes Investigational Site

New York, New York, 10032, United States

Location

Alkermes Investigational Site

New York, New York, 10035, United States

Location

Alkermes Investigational Site

Rochester, New York, 14642, United States

Location

Alkermes Investigational Site

Staten Island, New York, 10312, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Alkermes Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Alkermes Investigational Site

Scranton, Pennsylvania, 18503, United States

Location

Alkermes Investigational Site

Charleston, South Carolina, 29401, United States

Location

Alkermes Investigational Site

Charleston, South Carolina, 29407, United States

Location

Alkermes Investigational Site

Charleston, South Carolina, 29425, United States

Location

Alkermes Investigational Site

Austin, Texas, 78754, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75214, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

Burgas, 8000, Bulgaria

Location

Alkermes Investigational Site

Kazanlak, 6100, Bulgaria

Location

Alkermes Investigational Site

Lovech, 5500, Bulgaria

Location

Alkermes Investigational Site

Novi Iskar, 1282, Bulgaria

Location

Alkermes Investigational Site

Sofia, 1606, Bulgaria

Location

Alkermes Investigational Site

Tserova Koria, 8260, Bulgaria

Location

Alkermes Investigational Site

Varna, 9002, Bulgaria

Location

Alkermes Investigational Site

Varna, 9020, Bulgaria

Location

Alkermes Investigational Site

Vratsa, 3000, Bulgaria

Location

Alkermes Investigational Site

Bełchatów, 97-400, Poland

Location

Alkermes Investigational Site

Bialystok, 15-464, Poland

Location

Alkermes Investigational Site

Gdansk, 80-546, Poland

Location

Alkermes Investigational Site

Lublin, 20-109, Poland

Location

Related Publications (1)

• Brunette MF, Correll CU, O'Malley SS, McDonnell D, DiPetrillo L, Jiang Y, Simmons A, Silverman BL, Citrome L, Green AI. Olanzapine Plus Samidorphan (ALKS 3831) in Schizophrenia and Comorbid Alcohol Use Disorder: A Phase 2, Randomized Clinical Trial. J Clin Psychiatry. 2020 Mar 10;81(2):19m12786. doi: 10.4088/JCP.19m12786.

  PMID: 32160422 RESULT

MeSH Terms

Conditions

Schizophrenia; Alcoholism

Interventions

3-carboxamido-4-hydroxynaltrexone; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, Corporate and R&D Communications
• Organization: Alkermes

Gretchen.Murphy@alkermes.com

781-609-7000

Study Officials

• David McDonnell, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 12, 2014
• Study Start: May 1, 2014
• Primary Completion: January 11, 2017
• Study Completion: February 1, 2017
• Last Updated: October 8, 2021
• Results First Posted: October 8, 2021

Record last verified: 2021-09

Locations

BU (9); US (58); PL (4)