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NCT03818399 · ClinicalTrials.gov registry record · Phase 3
Virginia Opioid Overdose Treatment InitiatVE
A Phase 3 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT03818399: Clinical Trial Phase 3 study, sponsored by Virginia Commonwealth University.
NCT03818399 is a Phase 3 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818399, a Phase 3 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and receive treatment with an opioid antagonist. The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data. The study will assess subjects that receive acute administration of SUBOXONE sublingual film in the Emergency Department (ED) followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, compared to historical control data from electronic health records.
Primary Outcome
Repeat OD or opioid-related death will be measured from electronic medical records and state death registries
Interventions
- DRUG SUBLOCADE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-01-04 |
| Est. Completion | 2021-02-24 |
| Phase | Phase 3 |
Why NCT03818399 stopped before completion
NCT03818399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which SUBLOCADE is the first listed.
NCT03818399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03818399 about?
NCT03818399 is a clinical study titled "Virginia Opioid Overdose Treatment InitiatVE". This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and receive treatment with an opioid antagonist. The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data. The study will assess subjects that rece...
What is the current status of trial NCT03818399?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2019-01-04. Estimated completion is 2021-02-24.
What interventions are being tested in trial NCT03818399?
The interventions under investigation include: SUBLOCADE (DRUG).
Who is sponsoring clinical trial NCT03818399?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03818399's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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