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Could a tiny dose of naltrexone calm CRPS pain? new study aims to find out.

NCT ID NCT06306157

Symptom relief Sponsor: Hospital for Special Surgery, New York 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a very low dose of naltrexone, a drug usually used for addiction, can reduce pain and other symptoms in people with Complex Regional Pain Syndrome (CRPS). Forty adults with CRPS will receive either the drug or a placebo for six months. The main goal is to see if the study is practical to run, but researchers will also track pain scores and side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

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

Started

Jan 2024

Expected to finish

Nov 2026

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 to 85 years

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: * Between 18 and 85 years old * Meeting CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria * CRPS patients with severe pain (NRS\>3) that affects their daily life. * CRPS patients with pain and other symptoms for more than 3 months. Exclusion Criteria: * Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT). * Systemic or local infection * Malignancy * Current or planned pregnancy within the study period. * Uncontrolled medical and psychiatric condition * Patients with known liver issues, including but not limited to end-stage liver disease, severe cirrhosis or an acute hepatic state. * Patients who are currently using opioid drugs * Patients who are currently using alcohol or considering using alcohol during the study period. * Allergy to naltrexone or naloxone

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Conditions

The condition(s) this trial relates to.

agnosia Chronic Pain chronic pain syndrome complex regional pain syndrome complex regional pain syndrome type 1 complex regional pain syndrome type 2

As listed by the trial registrant

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

Causalgia Chronic pain Complex regional pain syndrome Complex regional pain syndrome type I Complex regional pain syndrome type II

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Hospital for Special Surgery

    New York, New York, 10021, United States

More trials for these conditions

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