At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 300 enrolled
Drug / intervention
Samidorphan + olanzapine (ALKS 3831) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder
In Brief
A Phase 2 clinical trial evaluating Samidorphan + olanzapine (ALKS 3831) and Placebo + olanzapine for Schizophrenia and Alcohol Use Disorder. Completed, enrolled 300 participants across 71 sites in 3 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Alcohol Use Disorder
CountriesBulgaria, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedJun 2014
Primary CompletionJan 2017
Study CompletionFeb 2017
TodayJul 2026
First PostedJun 12, 2014
Enrollment StartMay 1, 2014
Primary CompletionJan 11, 2017
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.1 years ago
Interventions
Samidorphan + olanzapine (ALKS 3831)drug
Oral tablet, taken once daily
Placebo + olanzapinedrug
Oral tablet, taken once daily