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Can a fast naloxone dose save hearts stopped by opioids?

NCT ID NCT06251609

Symptom relief Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether giving naloxone soon after resuscitation starts can help people whose hearts stop outside the hospital after an opioid overdose. The trial enrolls adults in out-of-hospital cardiac arrest who are at risk of opioid involvement and who have received standard resuscitation plus a first dose of epinephrine. Participants receive either naloxone or a saline placebo through an IV or directly into the bone, and the team tracks survival to hospital discharge and whether circulation returns. This pilot study checks whether a larger trial is feasible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naloxone, an opioid overdose antidote also known as Narcan
What this could lead to
If it works, naloxone could become a standard early step in resuscitating people whose hearts stop after an opioid overdose, potentially saving more lives.
What could go wrong
This is a small Phase 2 pilot with 98 patients, so it may not show a clear survival benefit. Naloxone can trigger sudden opioid withdrawal, and results may not apply to all cardiac arrest patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients will be eligible if all the following criteria are met: • Adults (age ≥ 18 years) in OHCA per EMS protocol. ACLS interventions have been initiated by EMS: chest compressions, ventilation; • 1st dose of epinephrine given via IV or IO. •. At risk of OA-OHCA (EMS presumed drug-related OHCA or NACARDI positive for occult OA-OHCA) as described above. Exclusion Criteria: * EMS plans to administer naloxone, or administration of naloxone by EMS during the same encounter * Cardiac arrest apparently caused by trauma, choking, or drowning. * Known or apparent pregnancy * Patient experiences ROSC prior to study drug administration * Prior inclusion in the study * Patient has an opt out bracelet or family member states exclusion •. Children less than 18 years old

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Conditions

The condition(s) this trial relates to.

acute opioid poisoning cardiac arrest Opiate Overdose Out-of-Hospital Cardiac Arrest

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart arrest, out-of-hospital Naloxone Opioid overdose

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California, San Francisco

    San Francisco, California, 94122, United States

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