Using low dose naltrexone to treat pain from spinal cord injuries
Low Dose Naltrexone in the Treatment of Central Neuropathic Pain After Traumatic Spinal Cord Injury: A Pilot Study
PHASE2 · Medical College of Wisconsin · NCT06723561
This study is testing if a low dose of naltrexone can help reduce pain and improve the quality of life for people with spinal cord injuries.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin (other) |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06723561 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the effectiveness of low dose naltrexone in reducing central neuropathic pain and improving quality of life for individuals with spinal cord injuries. Participants will take a daily oral dose of 4.5mg of naltrexone for 12 weeks, while their pain levels and quality of life will be assessed through various validated clinical tools and questionnaires. The study does not include a comparison group and is designed to gather preliminary data to inform a larger randomized control trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a traumatic cervical or thoracic spinal cord injury and central neuropathic pain.
Not a fit: Patients currently on chronic opioid treatment or those with central neuropathic pain from other causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and enhance the quality of life for patients suffering from spinal cord injury-related neuropathic pain.
How similar studies have performed: While low dose naltrexone has shown promise in other pain-related conditions, this specific application for spinal cord injury-related pain is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: Chen Cui, MD
- Email: chcui@mcw.edu
- Phone: 414-955-1922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Central Neuropathic Pain, Spinal Cord Injury, CNP, SCI, Naltrexone, Low Dose Naltrexone, LDN