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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: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Survival to hospital discharge is defined as patient is discharged from the hospital acute care unit alive regardless of neurological status, outcome or destination.
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 |
What is known before NCT06251609 opens enrollment
NCT06251609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Naloxone 2 MG is the first listed.
NCT06251609 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06251609's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 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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