MedTrace Logo

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

NCT02161718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-10-08

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Samidorphan + olanzapine (ALKS 3831)

Oral tablet, taken once daily

DRUG

Placebo + olanzapine

Oral tablet, taken once daily

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • David McDonnell, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-01-11
Completion
2017-02-01

Countries

  • United States
  • Bulgaria
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161718 on ClinicalTrials.gov