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

NCT ID: NCT06723561

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Central Neuropathic Pain; Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Dose Naltrexone

Daily dose of 4.5mg of naltrexone

Group Type: EXPERIMENTAL

4.5mg daily dose of naltrexone

Intervention Type: DRUG

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

Interventions

4.5mg daily dose of naltrexone

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Chen Cui

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chen Cui, MD

Role: CONTACT

chcui@mcw.edu

414-955-1922

Sarah Golus, BS

Role: CONTACT

sgolus@mcw.edu

414-955-1922

Facility Contacts

Chen Cui, MD

Role: primary

chcui@mcw.edu

414-955-1922

Other Identifiers

PRO 51429

Identifier Type: -

Identifier Source: org_study_id