Oxytocin and Pain Sensitivity and Threshold

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-07-31

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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intranasal Oxytocin

Administration of 32 units of Oxytocin administered intranasally

Group Type ACTIVE_COMPARATOR

Intranasal Oxytocin

Intervention Type DRUG

Administration of intranasal Oxytocin

Placebo (saline)

Administration of 4 sprays intranasally of normal saline.

Group Type PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type DRUG

Administration of normal saline intranasally.

Interventions

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Intranasal Oxytocin

Administration of intranasal Oxytocin

Intervention Type DRUG

Placebo (saline)

Administration of normal saline intranasally.

Intervention Type DRUG

Other Intervention Names

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Oxytocin normal saline

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes