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

Medical College of Wisconsin

Status and phase: Enrolling; Phase 2

Conditions: Central Neuropathic Pain; Spinal Cord Injury

Treatments: Drug: 4.5mg daily dose of naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT06723561

PRO 51429

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Low Dose Naltrexone

Experimental group

Description:

Daily dose of 4.5mg of naltrexone

Treatment:

Drug: 4.5mg daily dose of naltrexone