Efficacy of Spinal Oxytocin in Healthy Volunteers

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    36
  • sponsor
    Wake Forest University Health Sciences
Updated on 2 December 2021
Accepts healthy volunteers

Summary

The purpose of this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Description

Purpose: There is a strong experimental basis to support the study of oxytocin by the spinal route for analgesia in humans. Oxytocin containing cells in the dorsal parvocellular division of the paraventricular nucleus (PVN) project to the spinal cord (1). Noxious stimulation activates these cells via the A1 noradrenergic relay in the pons (2) and produces analgesia by spinal release of oxytocin, since intrathecal injection of an oxytocin receptor antagonist worsens pain behaviors from peripheral inflammation (3). Direct electrical stimulation of the PVN reduces dorsal horn neuronal responses to noxious stimulation, and this is blocked by administration of sequestering antibody for oxytocin (4). Similarly, direct electrical stimulation of the PVN reduces behavioral sensitivity in a model of chronic neuropathic pain, and this effect is blocked by an oxytocin receptor antagonist (5). Intrathecal injection of oxytocin in normal rats reduces dorsal horn neuronal responses to noxious stimuli (6) as well as behavioral responses to noxious thermal (3), mechanical (3), and chemical (7) stimuli. Finally, intrathecal injection of oxytocin in rat models of chronic pain also reduces dorsal horn neuronal responses to sensory stimulation (6) as well as behavioral responses to thermal (5) and mechanical (7) stimuli.

Rationale: We anticipate that oxytocin will be effective after spinal injection in humans against chemical induced hypersensitivity states.

Objectives: Determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Details
Condition Healthy Volunteer Study
Treatment Placebo, Oxytocin 15 mcg, Oxytocin 150 mcg
Clinical Study IdentifierNCT01996605
SponsorWake Forest University Health Sciences
Last Modified on2 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

healthy
weight < 240 pounds
American Society of Anesthesiology Category 1 or 2

Exclusion Criteria

allergy to oxytocin or lidocaine
allergy to chilli peppers
Females: active gynecological disease such as uterine fibroids or ongoing bleeding
Pregnancy or currently breastfeeding
Females that have delivered a baby within 2 years of study
Taking prescription medications (exception: oral birth control medication)
Clear my responses

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