Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury (NCT06723561) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury
United States10 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Evaluate LDN in the treatment of CNP after SCI
Timeframe: From enrollment to the end of treatment at 12 weeks