NCT02161718

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Samidorphan + olanzapine (ALKS 3831)	Oral tablet, taken once daily
DRUG	Placebo + olanzapine	Oral tablet, taken once daily

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-01-11
• Completion: 2017-02-01
• First posted: 2014-06-12
• Last updated: 2021-10-08
• Results posted: 2021-10-08

Locations

71 sites across 3 countries: United States, Bulgaria, Poland