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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 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 15 participants.
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.
Interventions
- DRUG Buprenorphine Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2023-02-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04283500
The ClinicalTrials.gov registry entry for NCT04283500 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine Naloxone is the first listed.
NCT04283500 reports 0 study locations.
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.
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