Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Rationale: The investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain.
Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.
Interventions: A computer generated randomization will be used to determine the group for each subject. Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: oxytocin oxytocin 100 micrograms administered intrathecally (IT) |
Drug: oxytocin 100 micrograms
oxytocin 100 micrograms administered intrathecally (IT)
|
| Placebo Comparator: normal saline preservative free normal saline: 3 milliliters administered intrathecally (IT) |
Drug: Normal Saline (preservative free)
Normal Saline (preservative free) administered intrathecally (IT)
|
Outcome Measures
Primary Outcome Measures
- Spontaneous pain from their neuropathic pain disease [60 minutes post injection]
Pain will be measured by visual analog scale, a 10 cm line with "no pain" on one end and "pain as worse as can be" on the other. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest School of Medicine | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: James C. Eisenach, M.D., Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00027272