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NCT02161718 · ClinicalTrials.gov registry record · Phase 2
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
A Phase 2 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT02161718: Completed Phase 2 study, sponsored by Alkermes.
NCT02161718 is a Phase 2 study that has completed, run by Alkermes. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02161718, a Phase 2 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study 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).
Primary Outcome
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 sc
Interventions
- DRUG Samidorphan + olanzapine (ALKS 3831)
- DRUG Placebo + olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 2 |
What the finished NCT02161718 record still lists
NCT02161718 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 2 interventions - of which Samidorphan + olanzapine (ALKS 3831) is the first listed.
NCT02161718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02161718 about?
NCT02161718 is a clinical study titled "A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder". This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
What is the current status of trial NCT02161718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2014-05. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT02161718?
The interventions under investigation include: Samidorphan + olanzapine (ALKS 3831) (DRUG), Placebo + olanzapine (DRUG).
Who is sponsoring clinical trial NCT02161718?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02161718's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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