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Clinical Trials/NCT01988649
NCT01988649
Withdrawn
Not Applicable

The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study

Northwestern University1 site in 1 countryApril 2015

Overview

Phase
Not Applicable
Intervention
Intranasal Oxytocin
Conditions
Pain
Sponsor
Northwestern University
Locations
1
Primary Endpoint
Pain sensitivity and threshold
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In addition,oxytocin have an important roles in sexual reproduction , in particular during and after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin has been commonly used to improve breastfeeding in lactating women. A review of safety , side effects and subjective reaction to intranasal oxytocin in human research in 1529 subjects did not review any differences from placebo. The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.4 Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain.

The main objective of the current investigation was to evaluate the effect of intranasal oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain threshold compared to intranasal saline .

Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain in humans.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
July 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Walega

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Healthy males and females volunteers
  • English speaking
  • Age \<20 and \> 35

Exclusion Criteria

  • Pregnancy
  • Lactation
  • Allergy to preservatives
  • Mental disease
  • Chronic pain
  • Current use of analgesics
  • Anxiety or depression Drop Out: volunteer request

Arms & Interventions

Intranasal Oxytocin

Administration of 32 units of Oxytocin administered intranasally

Intervention: Intranasal Oxytocin

Placebo (saline)

Administration of 4 sprays intranasally of normal saline.

Intervention: Placebo (saline)

Outcomes

Primary Outcomes

Pain sensitivity and threshold

Time Frame: 120 minutes

Pain sensitivity and threshold using the MEDoc device. Mechanical and thermal pain test will be performed at baseline, before drug administration, at 45 minutes and at 90 minutes.

Secondary Outcomes

  • Side effects of Oxytocin(2 Hours)

Study Sites (1)

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