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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Presence of a traumatic cervical or thoracic spinal cord injury

• Age ≥18

• \>6 months from time of injury

• Central neuropathic pain related to SCI, based on evaluation of a Physical Medicine \& Rehabilitation Physician

• DN4 questionnaire ≥ 4

• English speaking

Locations
United States
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Chen Cui, MD
chcui@mcw.edu
414-955-1922
Backup
Meghann Sytsma, BS
mesytsma@mcw.edu
414-955-1922
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Low Dose Naltrexone
Daily dose of 4.5mg of naltrexone
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov