NCT01988649

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

November 14, 2013

Last Update Submit

February 6, 2017

Conditions

Pain

Keywords

PainOxytocin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Side effects of Oxytocin

    2 Hours

Study Arms (2)

Intranasal Oxytocin

ACTIVE COMPARATOR

Administration of 32 units of Oxytocin administered intranasally

Drug: Intranasal Oxytocin

Placebo (saline)

PLACEBO COMPARATOR

Administration of 4 sprays intranasally of normal saline.

Drug: Placebo (saline)

Interventions

Intranasal OxytocinDRUG

Administration of intranasal Oxytocin

Also known as: Oxytocin
Intranasal Oxytocin
Placebo (saline)DRUG

Administration of normal saline intranasally.

Also known as: normal saline
Placebo (saline)

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related 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.

    PMID: 23055480BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

OxytocinSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • David Walega, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 20, 2013

Study Start

April 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

US(1)