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Could a tiny dose of naltrexone help spinal cord injury pain?

NCT ID NCT06723561

Symptom relief Sponsor: Medical College of Wisconsin 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 small pilot study is testing whether a daily low dose of naltrexone (4.5 mg) can reduce central neuropathic pain and improve quality of life in 10 adults with traumatic spinal cord injury. Participants take the drug for 12 weeks, and researchers measure pain scores and daily function. The goal is to gather initial data to plan a larger, more definitive trial.

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 10 people

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

Started

Feb 2025

Expected to finish

Dec 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 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: 1. Presence of a traumatic cervical or thoracic spinal cord injury 2. Age ≥18 3. \>6 months from time of injury 4. Central neuropathic pain related to SCI, based on evaluation of a Physical Medicine \& Rehabilitation Physician 5. DN4 questionnaire ≥ 4 6. English speaking Exclusion Criteria: 1. Adjustment in pain medications within the previous month 2. Chronic opioid treatment 3. Current treatment with naltrexone or other opioid antagonist 4. Allergy to naltrexone 5. Central neuropathic pain attributed to other etiology 6. Neuropathic pain attributed to the peripheral nervous system 7. PHQ9 ≥15 indicating moderately severe or severe depressive symptoms 8. Documented traumatic brain injury that would affect study participation, in the opinion of the investigator 9. Scheduled elective surgery during the duration of the study 10. Pregnant or breastfeeding 11. Illicit substance use per Wisconsin law

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

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

Central neuropathic pain Spinal cord injury

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

More trials for these conditions

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