Clinical trial NCT06723561: Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury
Official title: Low Dose Naltrexone in the Treatment of Central Neuropathic Pain After Traumatic Spinal Cord Injury: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Central Neuropathic Pain
Spinal Cord Injury
Keywords: Central Neuropathic Pain
CNP
Spinal Cord Injury
SCI
Naltrexone
Low Dose Naltrexone
LDN
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluate LDN in the treatment of CNP after SCI
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS).
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS).
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Evaluate improvement in quality of life using the Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL).
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: