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

Phase 2

Completed

• Conditions: Alcohol Use Disorder; Schizophrenia
• Interventions: Drug: Placebo + olanzapine; Drug: Samidorphan + olanzapine (ALKS 3831)

• Registration Number: NCT02161718
• Lead Sponsor: Alkermes, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Primary Completion: 2017-01-11
• Study Completion: 2017-02-01
• Disposition First Submitted: 2018-02-28
• Disposition First Submitted QC: 2018-02-28
• Disposition First Posted: 2018-03-01
• Results First Submitted: 2021-06-22
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Results First Posted: 2021-10-08
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + olanzapine	Placebo + olanzapine	-
Samidorphan + olanzapine (ALKS 3831)	Samidorphan + olanzapine (ALKS 3831)	Active study drug

Primary Outcome Measures

Name	Time	Method
Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)	Up to 15 months	EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization (includes psychiatric\& treatment of alcohol intoxication/withdrawal); 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score; 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease

Secondary Outcome Measures

Name	Time	Method
Number of Events of Exacerbation of Disease (EEDS)	Up to 15 months	EEDS was defined as any of the following occurring during the double-blind period \& was related to worsening of disease symptoms, as confirmed by the Independent Adjudication Committee (IAC): 1. Hospitalization(includes psychiatric \& treatment of alcohol intoxication/withdrawal); 2. \>= 25% or \>= 15 point increase from randomization in PANSS total score; 3. PANSS items score of P1, P2, P3, P6, P7 or G8 that meets 1 of the following: 3a. Score \>= 5 for subjects at a 2nd ad hoc visit with a score \<=3 at randomization 3b. Score \>= 6 for subjects at a 2nd ad hoc visit with a score =4 at randomization 4. Engagement in self injury, aggressive behavior, or suicidal/homicidal ideation 5. Initiation of rescue medication, including increase in olanzapine dosage initially prescribed at randomization 6. ER visit 7. Subject withdraws or PI discontinues subject for lack of efficacy, lost to follow-up, or withdrawal by subject 8. Arrest or incarceration related to subject's underlying disease
Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27)	24 weeks	Alcohol consumption per day = (total number of drinks x 14 gram) / (total number of days); WHO criteria for risk of alcohol consumption on a single drinking day: Abstinence- Males: 0 g; Females- 0 g Low Risk- Males: 1-40 g; Females: 1-20 g Medium Risk- Males: 41- 60 g; Females: 21- 40 g High Risk- Males: 61-100 g; Females: 41-60 g Very High Risk- Males: \>= 101 g; Females: \>= 61 g

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇵🇱 Lublin, Poland