Oxytocin and Pain Sensitivity and Threshold
Primary Purpose
Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intranasal Oxytocin
Placebo (saline)
Sponsored by
About this trial
This is an interventional basic science trial for Pain focused on measuring Pain, Oxytocin
Eligibility Criteria
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
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intranasal Oxytocin
Placebo (saline)
Arm Description
Administration of 32 units of Oxytocin administered intranasally
Administration of 4 sprays intranasally of normal saline.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Side effects of Oxytocin
Side effects including running nose, nasal irritation, tears in the eyes.
Full Information
NCT ID
NCT01988649
First Posted
November 14, 2013
Last Updated
February 6, 2017
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01988649
Brief Title
Oxytocin and Pain Sensitivity and Threshold
Official Title
The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Duplicate Study
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain, Oxytocin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Oxytocin
Arm Type
Active Comparator
Arm Description
Administration of 32 units of Oxytocin administered intranasally
Arm Title
Placebo (saline)
Arm Type
Placebo Comparator
Arm Description
Administration of 4 sprays intranasally of normal saline.
Intervention Type
Drug
Intervention Name(s)
Intranasal Oxytocin
Other Intervention Name(s)
Oxytocin
Intervention Description
Administration of intranasal Oxytocin
Intervention Type
Drug
Intervention Name(s)
Placebo (saline)
Other Intervention Name(s)
normal saline
Intervention Description
Administration of normal saline intranasally.
Primary Outcome Measure Information:
Title
Pain sensitivity and threshold
Description
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.
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Side effects of Oxytocin
Description
Side effects including running nose, nasal irritation, tears in the eyes.
Time Frame
2 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Walega, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23055480
Citation
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.
Results Reference
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Oxytocin and Pain Sensitivity and Threshold
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