The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold

Healthy 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: Completed

Administrative data

• NCT number: NCT02550093
• Other study ID #: STU86297
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: May 2022
• 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.The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: August 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

Exclusion Criteria:

• Pregnancy, lactation, allergy to preservatives, mental disease, any chronic pain and any current use of analgesics, anxiety or depression.

Related Conditions & MeSH terms

• Healthy
• Hypersensitivity

Intervention

Procedure:
• Intervention 1
Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 1 (Day 1).

Behavioral:
• Washout Period
The wash-out period will be between intervention 1 and intervention 2. 13 days in length.

Procedure:
• Intervention 2
Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 2 (Day 14).

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Fewtrell MS, Loh KL, Blake A, Ridout DA, Hawdon J. Randomised, double blind trial of oxytocin nasal spray in mothers expressing breast milk for preterm infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F169-74. Epub 2005 Oct 13. — View Citation

MacDonald E, Dadds MR, Brennan JL, Williams K, Levy F, Cauchi AJ. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrinology. 2011 Sep;36(8):1114-26. doi: 10.1016/j.psyneuen.2011.02.015. Epub 2011 Mar 23. Review. — View Citation

Rash JA, Aguirre-Camacho A, Campbell TS. Oxytocin and pain: a systematic review and synthesis of findings. Clin J Pain. 2014 May;30(5):453-62. doi: 10.1097/AJP.0b013e31829f57df. Review. — View Citation

Singer T, Snozzi R, Bird G, Petrovic P, Silani G, Heinrichs M, Dolan RJ. Effects of oxytocin and prosocial behavior on brain responses to direct and vicariously experienced pain. Emotion. 2008 Dec;8(6):781-91. doi: 10.1037/a0014195. — View Citation

Wang YL, Yuan Y, Yang J, Wang CH, Pan YJ, Lu L, Wu YQ, Wang DX, Lv LX, Li RR, Xue L, Wang XH, Bi JW, Liu XF, Qian YN, Deng ZK, Zhang ZJ, Zhai XH, Zhou XJ, Wang GL, Zhai JX, Liu WY. The interaction between the oxytocin and pain modulation in headache patients. Neuropeptides. 2013 Apr;47(2):93-7. doi: 10.1016/j.npep.2012.12.003. Epub 2013 Jan 30. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius.	Thermal Sensory Threshold for Pain at baseline prior to study drug administration. Evaluation of subjects baseline responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The baseline response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C.	Baseline
Primary	Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius.	Thermal Sensory Threshold for Pain at 45 minutes after study drug administration. Evaluation of subjects responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C.	45 minutes
Primary	Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius.	Thermal Sensory Threshold for Pain at 90 minutes after study drug administration. Evaluation of subjects responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C.	90 minutes
Primary	Mechanical Pain Threshold for Pain at Baseline in Grams.	Mechanical pain threshold for pain at baseline utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain.	Baseline
Primary	Mechanical Pain Threshold for Pain at 45 Minutes in Grams.	Mechanical pain threshold for pain at 45 minutes utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain.	45 minutes
Primary	Mechanical Pain Threshold for Pain at 90 Minutes in Grams.	Mechanical pain threshold for pain at 90 minutes utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain.	90 minutes
Primary	Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores.	Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable).	Baseline
Primary	Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores.	Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable).	45 minutes
Primary	Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores.	Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable).	90 minutes
Primary	Thermal Wind-up Pain Assessment at Baseline	Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable).	Baseline
Primary	Thermal Wind-up Pain at 45 Minutes	Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable).	45 minutes
Primary	Thermal Wind-up Pain at 90 Minutes	Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable).	90 minutes