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

Alkermes

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Alcohol Use Disorder

Treatments: Drug: Placebo + olanzapine; Drug: Samidorphan + olanzapine (ALKS 3831)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02161718

ALK3831-401

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Samidorphan + olanzapine (ALKS 3831)

Experimental group

Description:

Active study drug

Treatment:

Drug: Samidorphan + olanzapine (ALKS 3831)

Placebo + olanzapine

Placebo Comparator group

Treatment:

Drug: Placebo + olanzapine