Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury

April 29, 2026 updated by: Chen Cui, Medical College of Wisconsin

Low Dose Naltrexone in the Treatment of Central Neuropathic Pain After Traumatic Spinal Cord Injury: A Pilot Study

The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury.

Hypothesis 1: LDN will decrease the severity of CNP in adult patients with SCI as measured by the Neuropathic Pain Scale (NPS) Hypothesis 2: LDN will improve quality of life of patients with SCI as measured by various validated clinical tools

There is no comparison group. This study is being completed to give investigators more information for how to best run a larger clinical trial.

Participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is being completed to provide the first evidence that low dose naltrexone may be able to lower pain and improve quality of life for people with pain due to spinal cord injury. Data from this study will be used to plan a larger, randomized control trial. If eligible, participants will take a daily low dose naltrexone pill (4.5mg) by mouth for 12 weeks. Study participants will keep a daily medicine log and a daily sleep log. The study team will check in regularly (virtual visits) with the participants and give questionnaires verbally.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose Naltrexone
Daily dose of 4.5mg of naltrexone
Drug: 4.5mg daily dose of naltrexone
Study subjects will take a daily 4.5mg dose of naltrexone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate LDN in the treatment of CNP after SCI
Time Frame: From enrollment to the end of treatment at 12 weeks
Generate initial data to calculate an effect size of LDN in the treatment of CNP in SCI. This will be utilized to plan a randomized control trial and submit for extramural funding.
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS).
Time Frame: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS). Participants report a pain score from 0 - no pain, to 10 - the worst pain possible. A lower score is a better outcome.
From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS)
Time Frame: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS). Participants report a score between 0 - Pain did not interfere with sleep to 10 - Pain completely interfered with sleep, or was unable to sleep due to pain. A lower score is a better outcome.
From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC)
Time Frame: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC) . Participants report a pain score of overall change in status from 1 - Very much improved to 7 - Very much worse. A lower score is a better outcome.
From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS).
Time Frame: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS). Participants report a pain score from 0 - no pain, to 10 - the worst pain possible. A lower score is a better outcome.
From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL).
Time Frame: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL). Participants respond to a series of questions about how much pain due to spinal cord injury affects quality of life answering from 1 - Not at all, to 7 - Very much. A lower score is a better outcome.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO 51429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is a pilot study. Data will be used to plan a larger randomized control trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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