This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Oral tablet, taken once daily
Oral tablet, taken once daily
Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS)
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
Time frame: Up to 15 months
Number of Events of Exacerbation of Disease (EEDS)
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
Time frame: Up to 15 months
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)
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Springdale, Arkansas, United States
Alkermes Investigational Site
Anaheim, California, United States
Alkermes Investigational Site
Culver City, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Irvine, California, United States
Alkermes Investigational Site
La Jolla, California, United States
Alkermes Investigational Site
Long Beach, California, United States
Alkermes Investigational Site
National City, California, United States
Alkermes Investigational Site
Oakland, California, United States
...and 61 more locations
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
Time frame: 24 weeks