Clinical trial NCT02550093: The Effect of Intranasal Oxytocin on 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius.
timeFrame: Baseline
measure: Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius.
timeFrame: 45 minutes
measure: Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius.
timeFrame: 90 minutes
measure: Mechanical Pain Threshold for Pain at Baseline in Grams.
timeFrame: Baseline
measure: Mechanical Pain Threshold for Pain at 45 Minutes in Grams.
timeFrame: 45 minutes
measure: Mechanical Pain Threshold for Pain at 90 Minutes in Grams.
timeFrame: 90 minutes
measure: Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores.
timeFrame: Baseline
measure: Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores.
timeFrame: 45 minutes
measure: Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores.
timeFrame: 90 minutes
measure: Thermal Wind-up Pain Assessment at Baseline
timeFrame: Baseline
measure: Thermal Wind-up Pain at 45 Minutes
timeFrame: 45 minutes
measure: Thermal Wind-up Pain at 90 Minutes
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: David R Walega, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1136/adc.2005.081265. Epub 2005 Oct 13.
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.
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.
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.
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.