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

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.

Conditions

Central Neuropathic Pain, Spinal Cord Injury

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Central Neuropathic Pain
Intervention / Treatment

-

Contacts and Locations

Milwaukee

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical College of Wisconsin,

Study Record Dates

2026-12-31