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NCT05118204 · ClinicalTrials.gov registry record · Phase 4
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
A Phase 4 study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT05118204: Clinical Trial Phase 4 study, sponsored by Montefiore Medical Center.
NCT05118204 is a Phase 4 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05118204, a Phase 4 study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking. The treatment as usual (TAU) has participants stop other opioids and experience opioid withdrawal before starting BUP. Investigators propose to test BUP microdose inductions vs. TAU in a randomized controlled trial.
Primary Outcome
The percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.
Interventions
- DRUG TAU
- DRUG BUP microdose induction
- BEHAVIORAL Linkage to outpatient BUP treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2022-09-29 |
| Est. Completion | 2025-04-09 |
| Phase | Phase 4 |
Why NCT05118204 stopped before completion
NCT05118204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which TAU is the first listed.
NCT05118204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05118204 about?
NCT05118204 is a clinical study titled "Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization". Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking. The treatment as usual (TAU) has participants stop other opioids and ex...
What is the current status of trial NCT05118204?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2022-09-29. Estimated completion is 2025-04-09.
What interventions are being tested in trial NCT05118204?
The interventions under investigation include: TAU (DRUG), BUP microdose induction (DRUG), Linkage to outpatient BUP treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT05118204?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05118204's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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