Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James C. Eisenach, M.D.; Wake Forest University Health Sciences
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• Weight < or equal to 240 pounds

• Neuropathic pain for > 6 months: with primary pain area below the umbilicus

Exclusion Criteria:

• Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine

• Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data

• Pregnancy

• spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for > 3 months at a current dose of > 100 milligram (mg) morphine per day or equivalent.