Oxytocin and Pain Sensitivity and Threshold

Not Applicable

Withdrawn

• Conditions: Pain
• Interventions: Drug: Intranasal Oxytocin; Drug: Placebo (saline)

• Registration Number: NCT01988649
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-20
• Study Start: 2015-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intranasal Oxytocin	Intranasal Oxytocin	Administration of 32 units of Oxytocin administered intranasally
Placebo (saline)	Placebo (saline)	Administration of 4 sprays intranasally of normal saline.

Primary Outcome Measures

Name	Time	Method
Pain sensitivity and threshold	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 Outcome Measures

Name	Time	Method
Side effects of Oxytocin	2 Hours	Side effects including running nose, nasal irritation, tears in the eyes.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States