Treating Central Neuropathic Pain With Low Dose Naltrexon... | NCT06723561

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

NCT06723561

Sponsor

Medical College of Wisconsin

Status

Active, not recruiting

Last Update Posted

Apr 30, 2026Actual

Enrollment

10Estimated

Phase

Phase 2

Conditions

Central Neuropathic Pain
Spinal Cord Injury

Interventions

4.5mg daily dose of naltrexone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 26, 2024

First Submission Date that Met QC Criteria

Dec 4, 2024

First Posted Date

Dec 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

Apr 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Dose Naltrexone	Experimental	Daily dose of 4.5mg of naltrexone	Drug: 4.5mg daily dose of naltrexone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
4.5mg daily dose of naltrexone	Drug	Study subjects will take a daily 4.5mg dose of naltrexone.	Low Dose Naltrexone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate LDN in the treatment of CNP after SCI	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.	From enrollment to the end of treatment at 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS).	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.	From enrollment to the end of treatment at 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical College of Wisconsin		Milwaukee	Wisconsin	53226	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

This is a pilot study. Data will be used to plan a larger randomized control trial.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided