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

Phase 2
Waitlist Available
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Presence of a traumatic cervical or thoracic spinal cord injury
2. Age ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the end of treatment at 12 weeks
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Central Neuropathic Pain
  • Spinal Cord Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of treatment at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of treatment at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate LDN in the treatment of CNP after SCI
Secondary study objectives
Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS)
Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS).
Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS).
+2 more

Side effects data

From 2019 Phase 2 trial • 29 Patients • NCT03008590
7%
Dizziness
3%
Ankle injury
3%
Infections, minor viral or bacterial
3%
Fatigue
3%
Lip and tongue swelling
3%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
During Placebo Treatment
During Naltrexone Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Low Dose NaltrexoneExperimental Treatment1 Intervention
Daily dose of 4.5mg of naltrexone

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
634 Previous Clinical Trials
1,181,695 Total Patients Enrolled
~7 spots leftby Jun 2026
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