RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06723561

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Presence of a traumatic cervical or thoracic spinal cord injury
  2. 2. Age ≥18
  3. 3. \>6 months from time of injury
  4. 4. Central neuropathic pain related to SCI, based on evaluation of a Physical Medicine \& Rehabilitation Physician
  5. 5. DN4 questionnaire ≥ 4
  6. 6. English speaking
  1. 1. Adjustment in pain medications within the previous month
  2. 2. Chronic opioid treatment
  3. 3. Current treatment with naltrexone or other opioid antagonist
  4. 4. Allergy to naltrexone
  5. 5. Central neuropathic pain attributed to other etiology
  6. 6. Neuropathic pain attributed to the peripheral nervous system
  7. 7. PHQ9 ≥15 indicating moderately severe or severe depressive symptoms
  8. 8. Documented traumatic brain injury that would affect study participation, in the opinion of the investigator
  9. 9. Scheduled elective surgery during the duration of the study
  10. 10. Pregnant or breastfeeding
  11. 11. Illicit substance use per Wisconsin law

Contacts and Locations

Study Contact

Chen Cui, MD
CONTACT
414-955-1922
chcui@mcw.edu
Meghann Sytsma, BS
CONTACT
414-955-1922
mesytsma@mcw.edu

Study Locations (Sites)

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-02-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Central Neuropathic Pain
  • CNP
  • Spinal Cord Injury
  • SCI
  • Naltrexone
  • Low Dose Naltrexone
  • LDN

Additional Relevant MeSH Terms

  • Central Neuropathic Pain
  • Spinal Cord Injury