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NCT04345718 · ClinicalTrials.gov registry record · Phase 2
EXHIT ENTRE Comparative Effectiveness Trial
A Phase 2 study, sponsored by Gavin Bart.
- Completed
- Registry status
- Phase 2
- Development phase
- 344
- Enrollment target
NCT04345718: Completed Phase 2 study, sponsored by Gavin Bart.
NCT04345718 is a Phase 2 study that has completed, run by Gavin Bart. The registered enrollment target is 344 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04345718, a Phase 2 study, has completed, sponsored by Gavin Bart.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 344 participants
- Enrollment target
Study Summary
This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.
Primary Outcome
Engagement in OUD is defined as coverage with a legitimately prescribed MOUD on that 34th day regardless of the source of prescribed MOUD coverage (e.g., formalized treatment program, primary care, jail, etc.).
Interventions
- DRUG Extended Release Buprenorphine
- DRUG Treatment as Usual
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 2 |
What the finished NCT04345718 record still lists
NCT04345718 is an interventional study that assigns participants to a tested intervention. The registered 344 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 (159% higher).
The record links to 0 conditions, and to 2 interventions - of which Extended Release Buprenorphine is the first listed.
NCT04345718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04345718 about?
NCT04345718 is a clinical study titled "EXHIT ENTRE Comparative Effectiveness Trial". This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service ...
What is the current status of trial NCT04345718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 344 participants. The study started on 2021-08-09. Estimated completion is 2025-08-27.
What interventions are being tested in trial NCT04345718?
The interventions under investigation include: Extended Release Buprenorphine (DRUG), Treatment as Usual (DRUG).
Who is sponsoring clinical trial NCT04345718?
This trial is sponsored by Gavin Bart, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04345718's enrollment target sits among peer trials
344 136th of 2000 higher than 1,865 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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