The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study
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- Withdrawn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.
Investigators
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)