Efficacy of Spinal Oxytocin in Healthy Volunteers

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  • sponsor
    Wake Forest University Health Sciences
Updated on 2 December 2021
Accepts healthy volunteers


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.


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.

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


Yes No Not Sure

Inclusion Criteria

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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