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NCT Number: NCT06723561

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Central Neuropathic Pain Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

This study is being completed to provide the first evidence that low dose naltrexone may be able to lower pain and improve quality of life for people with pain due to spinal cord injury. Data from this study will be used to plan a larger, randomized control trial. If eligible, participants will take a daily low dose naltrexone pill (4.5mg) by mouth for 12 weeks. Study participants will keep a daily medicine log and a daily sleep log. The study team will check in regularly (virtual visits) with the participants and give questionnaires verbally.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

4.5mg daily dose of naltrexone

Drug

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

Primary outcomes

  1. Evaluate LDN in the treatment of CNP after SCI

    Time frame: From enrollment to the end of treatment at 12 weeks

    Generate initial data to calculate an effect size of LDN in the treatment of CNP in SCI. This will be utilized to plan a randomized control trial and submit for extramural funding.

Secondary outcomes

  1. Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS).

    Time frame: From enrollment to the end of treatment at 12 weeks

    Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS). Participants report a pain score from 0 - no pain, to 10 - the worst pain possible. A lower score is a better outcome.

  2. Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS). Participants report a score between 0 - Pain did not interfere with sleep to 10 - Pain completely interfered with sleep, or was unable to sleep due to pain. A lower score is a better outcome.

  3. Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC) . Participants report a pain score of overall change in status from 1 - Very much improved to 7 - Very much worse. A lower score is a better outcome.

  4. Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS).

    Time frame: From enrollment to the end of treatment at 12 weeks

    Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS). Participants report a pain score from 0 - no pain, to 10 - the worst pain possible. A lower score is a better outcome.

  5. Evaluate improvement in quality of life using the Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL).

    Time frame: From enrollment to the end of treatment at 12 weeks

    Evaluate improvement in quality of life using the Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL). Participants respond to a series of questions about how much pain due to spinal cord injury affects quality of life answering from 1 - Not at all, to 7 - Very much. A lower score is a better outcome.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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