Clinical trial NCT02161718: A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
Official title: A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Alcohol Use Disorder
Keywords: Alkermes
Schizophrenia
Alcohol Use Disorder
ALKS 3831
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)
timeFrame: Up to 15 months
Secondary outcomes:
measure: Number of Events of Exacerbation of Disease (EEDS)
timeFrame: Up to 15 months
measure: 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)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Alkermes Investigational Site
state: California
city: Culver City
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Irvine
country: United States
facility: Alkermes Investigational Site
state: California
city: La Jolla
country: United States
facility: Alkermes Investigational Site
state: California
city: Long Beach
country: United States
facility: Alkermes Investigational Site
state: California
city: National City
country: United States
facility: Alkermes Investigational Site
state: California
city: Oakland
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: San Francisco
country: United States
facility: Alkermes Investigational Site
state: California
city: Torrance
country: United States
facility: Alkermes Investigational Site
state: California
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Maitland
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: North Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Tampa
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Shreveport
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Worcester
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Flowood
country: United States
facility: Alkermes Investigational Site
state: Mississippi
city: Creve Coeur
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Claremont
country: United States
facility: Alkermes Investigational Site
state: New Hampshire
city: Nashua
country: United States
facility: Alkermes Investigational Site
state: New Hampshire
city: Neptune
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Cedarhurst
country: United States
facility: Alkermes Investigational Site
state: New York
city: Jamaica
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: Rochester
country: United States
facility: Alkermes Investigational Site
state: New York
city: Staten Island
country: United States
facility: Alkermes Investigational Site
state: New York
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Scranton
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Burgas
country: Bulgaria
facility: Alkermes Investigational Site
city: Kazanlak
country: Bulgaria
facility: Alkermes Investigational Site
city: Lovech
country: Bulgaria
facility: Alkermes Investigational Site
city: Novi Iskar
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Tserova Koria
country: Bulgaria
facility: Alkermes Investigational Site
city: Varna
country: Bulgaria
facility: Alkermes Investigational Site
city: Varna
country: Bulgaria
facility: Alkermes Investigational Site
city: Vratsa
country: Bulgaria
facility: Alkermes Investigational Site
city: Belchatow
country: Poland
facility: Alkermes Investigational Site
city: Bialystok
country: Poland
facility: Alkermes Investigational Site
city: Gdansk
country: Poland
facility: Alkermes Investigational Site
city: Lublin
country: Poland
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: David McDonnell, MD
role: STUDY_DIRECTOR
References:
citation: 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.