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NCT06251609 · ClinicalTrials.gov registry record · Phase 2
Naloxone for Opioid Associated Out of Hospital Cardiac Arrest
A Phase 2 study, sponsored by University of California, San Francisco.
- Not yet
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT06251609 is a Phase 2 study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 98 participants.
The verdict
NCT06251609, a Phase 2 study, has not yet begun recruiting, sponsored by University of California, San Francisco.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.
Interventions
- DRUG Naloxone 2 MG
- DRUG Saline 2ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2026-11 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06251609
The ClinicalTrials.gov registry entry for NCT06251609 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Naloxone 2 MG is the first listed.
NCT06251609 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06251609 about?
NCT06251609 is a clinical study titled "Naloxone for Opioid Associated Out of Hospital Cardiac Arrest". The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to r...
What is the current status of trial NCT06251609?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2026-11. Estimated completion is 2028-12-31.
What interventions are being tested in trial NCT06251609?
The interventions under investigation include: Naloxone 2 MG (DRUG), Saline 2ml (DRUG).
Who is sponsoring clinical trial NCT06251609?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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