Oxytocin and Pain Sensitivity and Threshold

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Intranasal Oxytocin
* Drug: Placebo (saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intranasal Oxytocin<br>Administration of 32 units of Oxytocin administered intranasally | Drug: Intranasal Oxytocin<br>* Administration of intranasal Oxytocin<br>* Other names: Oxytocin;|
| Placebo Comparator: Placebo (saline)<br>Administration of 4 sprays intranasally of normal saline. | Drug: Placebo (saline)<br>* Administration of normal saline intranasally.<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of Oxytocin | Side effects including running nose, nasal irritation, tears in the eyes. | 2 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Oxytocin