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Efficacy of Spinal Oxytocin in Healthy Volunteers

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Terminated
CT.gov ID
NCT01996605
Collaborator
(none)
20
Enrollment
1
Location
3
Arms
105.2
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxytocin 15 mcg
  • Drug: Oxytocin 150 mcg
  • Drug: Placebo
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Efficacy of Intrathecal Oxytocin in Human Volunteers
Study Start Date :
Jan 2, 2014
Actual Primary Completion Date :
Oct 10, 2022
Actual Study Completion Date :
Oct 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oxytocin 15 mcg

Oxytocin 15 mcg injected spinally

Drug: Oxytocin 15 mcg
Oxytocin 15 mcg will be administered spinally
Experimental: Oxytocin 150 mcg

Oxytocin 150 mcg injected spinally

Drug: Oxytocin 150 mcg
Oxytocin 150 mcg will be administered spinally
Active Comparator: Placebo

Preservative free normal saline injected spinally

Drug: Placebo
placebo will be administered spinally

Outcome Measures

Primary Outcome Measures

  1. Hyperalgesia [105 minutes]

    The area of hyperalgesia after the first skin heating following topical capsaicin.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: James C Eisenach, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01996605
Other Study ID Numbers:
  • IRB00025901
First Posted:
Nov 27, 2013
Last Update Posted:
Dec 7, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Oxytocin

Study Results

No Results Posted as of Dec 7, 2022