RecruitingPhase 2NCT06723561

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


Sponsor

Medical College of Wisconsin

Enrollment

10 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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

Exclusion Criteria11

  • Adjustment in pain medications within the previous month
  • Chronic opioid treatment
  • Current treatment with naltrexone or other opioid antagonist
  • Allergy to naltrexone
  • Central neuropathic pain attributed to other etiology
  • Neuropathic pain attributed to the peripheral nervous system
  • PHQ9 ≥15 indicating moderately severe or severe depressive symptoms
  • Documented traumatic brain injury that would affect study participation, in the opinion of the investigator
  • Scheduled elective surgery during the duration of the study
  • Pregnant or breastfeeding
  • Illicit substance use per Wisconsin law

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Interventions

DRUG4.5mg daily dose of naltrexone

Study subjects will take a daily 4.5mg dose of naltrexone.


Locations(1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT06723561


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