Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2025-12-24 @ 12:25 PM
NCT ID:
NCT06723561
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06723561
Study Brief:
Protocol Section:
NCT06723561