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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Ethanol; Olanzapine

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