Central Neuropathic PainPhase 2NCT06723561
Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury
A Phase 2 study testing 4.5mg daily dose of naltrexone in people with Central Neuropathic Pain and Spinal Cord Injury, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Neuropathic Pain, Spinal Cord Injury
- What is being tested?
- 4.5mg daily dose of naltrexone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Low Dose Naltrexone in the Treatment of Central Neuropathic Pain After Traumatic Spinal Cord Injury: A Pilot Study
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
Read more
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.
Read the 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
- Being tested
- 4.5mg daily dose of naltrexone
- Keywords
- Central Neuropathic Pain, CNP, Spinal Cord Injury, SCI, Naltrexone, Low Dose Naltrexone, LDN
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4.5mg daily dose of naltrexoneDrug
Study subjects will take a daily 4.5mg dose of naltrexone.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Naltrexone | Experimental | Daily dose of 4.5mg of naltrexone Receives: Drug: 4.5mg daily dose of naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS).
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.
Measured: 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).
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Feb 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Cui, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723561
- Sponsor's protocol ID
- PRO 51429
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilot study. Data will be used to plan a larger randomized control trial.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Naltrexone in the Treatment of Central Neuropathic Pain After Traumatic Spinal Cord Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT06723561
- Acronym / sponsor ID
- PRO 51429
- Conditions
- Central Neuropathic Pain, Spinal Cord Injury
- Keywords
- Central Neuropathic Pain, CNP, Spinal Cord Injury, SCI, Naltrexone, Low Dose Naltrexone, LDN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Dose Naltrexone | Experimental | Drug: 4.5mg daily dose of naltrexoneDaily dose of 4.5mg of naltrexone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4.5mg daily dose of naltrexoneStudy subjects will take a daily 4.5mg dose of naltrexone. | Drug | Low Dose Naltrexone |
Primary outcome
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.
5 secondary outcomes
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 Daily Sleep Interference Scale (DSIS)
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)
Time frame: From enrollment to the end of treatment at 12 weeks
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 Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL).
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided. This is a pilot study. Data will be used to plan a larger randomized control trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4.5mg daily dose of naltrexone in people with Central Neuropathic Pain and Spinal Cord Injury, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate LDN in the treatment of CNP after SCI (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.