Oxytocin and Pain Sensitivity and Threshold

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01988649
• Other study ID #: STU00086297
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2013
• Last updated: February 6, 2017
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: February 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Intranasal Oxytocin
Administration of intranasal Oxytocin
• Placebo (saline)
Administration of normal saline intranasally.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yamasue H, Yee JR, Hurlemann R, Rilling JK, Chen FS, Meyer-Lindenberg A, Tost H. Integrative approaches utilizing oxytocin to enhance prosocial behavior: from animal and human social behavior to autistic social dysfunction. J Neurosci. 2012 Oct 10;32(41):14109-17. doi: 10.1523/JNEUROSCI.3327-12.2012. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain sensitivity and threshold	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.	120 minutes
Secondary	Side effects of Oxytocin	Side effects including running nose, nasal irritation, tears in the eyes.	2 Hours