Efficacy of Spinal Oxytocin in Healthy Volunteers
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 59 |
| Updated: | 12/30/2018 |
| Start Date: | June 2014 |
| End Date: | December 2020 |
Efficacy of Intrathecal Oxytocin in Human 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.
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.
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.
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)
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Principal Investigator: James C Eisenach, MD
Phone: 336-716-4294
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