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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Alcohol Use Disorder

In brief

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

Key facts

Study ID

NCT02161718

Run by

Alkermes, Inc.

People needed

300

Starts

2014-05-01

Expected to finish

2017-02-01

Last updated by the study team

2021-10-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Alkermes Investigational Site — Springdale, Arkansas, United States
• Alkermes Investigational Site — Anaheim, California, United States
• Alkermes Investigational Site — Culver City, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Irvine, California, United States
• Alkermes Investigational Site — La Jolla, California, United States
• Alkermes Investigational Site — Long Beach, California, United States
• Alkermes Investigational Site — National City, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — San Francisco, California, United States
• Alkermes Investigational Site — Torrance, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Fort Lauderdale, Florida, United States
• Alkermes Investigational Site — Leesburg, Florida, United States
• Alkermes Investigational Site — Maitland, Florida, United States
• Alkermes Investigational Site — Miami, Florida, United States
• Alkermes Investigational Site — Miami, Florida, United States
• Alkermes Investigational Site — North Miami, Florida, United States
• Alkermes Investigational Site — Oakland Park, Florida, United States
• Alkermes Investigational Site — Orlando, Florida, United States
• Alkermes Investigational Site — Tampa, Florida, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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