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Can a pinch of naloxone stop opioids from making pain worse?

NCT ID NCT03066739

Symptom relief Sponsor: University of California, Irvine 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small, early-phase study tested whether adding an ultra-low dose of naloxone to a strong opioid (remifentanil) could prevent the increased pain sensitivity that sometimes happens after surgery. The trial involved 8 adults undergoing spinal fusion surgery. The study was terminated early, so the results are not conclusive.

What this could mean

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

Active substance
naloxone (ultra-low dose) combined with remifentanil
What this could lead to
If it works, this could point toward a way to prevent increased pain sensitivity caused by strong opioids during surgery.
What could go wrong
The trial was terminated early with only 8 participants, so results are very limited and may not be reliable. It is unclear if the approach works or is safe.

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

8 people

The number who actually took part.

Started

Feb 2023

Finished

Dec 2025

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: * Subjects who provide written informed consent. * Age 18 years old or older (no upper age limit for inclusion) * Gender: male or female. * Surgery: Posterior spinal fusions Exclusion Criteria: * Allergy to opiates * Chronic pain other than the primary indication for surgery * Psychiatric illness * History of substance abuse problem including alcohol \&/or cannabis * BMI \> 35 * Subjects under 18 years of age. * Subject without the capacity to give written informed consent. 8. Female subjects who are pregnant

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Conditions

The condition(s) this trial relates to.

Hyperalgesia

As listed by the trial registrant

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

Hyperalgesia

Contacts and locations

Locations

  • UC Irvine Medical Center

    Orange, California, 92868, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.