NCT06723561

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Central Neuropathic Pain
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	4.5mg daily dose of naltrexone	Study subjects will take a daily 4.5mg dose of naltrexone.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-12-09
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study