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NCT04283500 · ClinicalTrials.gov registry record · Phase 4

Buprenorphine Loading in the Emergency Department

A Phase 4 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
15
Enrollment target

NCT04283500: Completed Phase 4 study, sponsored by NYU Langone Health.

NCT04283500 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04283500, a Phase 4 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
15 participants
Enrollment target

Study Summary

Buprenorphine (BUP) is FDA-approved for the treatment of opioid withdrawal and opioid use disorder. Few ED providers have received the necessary DEA registration (aka X waiver) required to prescribe BUP, and urgent appointments to continue ongoing BUP treatment may not be readily available, thus leading to medication discontinuity. A loading dose induction strategy with 32mg of BUP may help effectively link ED patients to outpatient treatment while minimizing known barriers to ED uptake. Administering a "loading dose" of BUP to saturate mu-opioid receptors would extend the duration of action and provide additional time to secure ongoing treatment. Further, BUP's ceiling effect on respiratory depression makes it a remarkably safe drug even at high doses. In recent years, ED providers have begun to incorporate this approach into clinical protocols, however, it has not been formally studied in this clinical setting. The investigator's study represents the necessary step of studying this novel approach in the ED setting to define the parameters for clinical protocols and large-scale studies.

Primary Outcome

This will be measured by the proportion of participants who report Successful Rapid Induction. Participants will receive a loading dose of BUP SL 32mg in the ED without experiencing a clinically significant serious and/or severe adverse event (AE) related to the intervention - specifically, the receipt of a dose of BUP SL greater than 8mg during the Index ED visit. Successful rapid induction is defined only by the outcome of the participant's visit, and not by any following research visits.

Interventions

  • DRUG Buprenorphine Naloxone

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2020-11-01
Est. Completion 2023-02-25
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT04283500 record still lists

NCT04283500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Buprenorphine Naloxone is the first listed.

NCT04283500 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04283500 about?

NCT04283500 is a clinical study titled "Buprenorphine Loading in the Emergency Department". Buprenorphine (BUP) is FDA-approved for the treatment of opioid withdrawal and opioid use disorder. Few ED providers have received the necessary DEA registration (aka X waiver) required to prescribe BUP, and urgent appointments to continue ongoing BUP treatment may not be readily available, thus lea...

What is the current status of trial NCT04283500?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2020-11-01. Estimated completion is 2023-02-25.

What interventions are being tested in trial NCT04283500?

The interventions under investigation include: Buprenorphine Naloxone (DRUG).

Who is sponsoring clinical trial NCT04283500?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04283500's enrollment target sits among peer trials

15 1880th of 2000 higher than 100 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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Source: ClinicalTrials.gov NCT04283500, the US trial registry maintained by the National Library of Medicine. NCT04283500 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.