The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold
NCT ID: NCT02550093
Last Updated: 2022-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2015-04-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Oxytocin, then Normal Saline
Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 13 days the same subject will then receive a nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 2 (day 14).
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).
Washout Period
The wash-out period will be between intervention 1 and intervention 2. 13 days in length.
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).
Normal Saline, then Oxytocin
Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 14 to 15 days the same subject will then receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 2 (day 14).
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).
Washout Period
The wash-out period will be between intervention 1 and intervention 2. 13 days in length.
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).
Interventions
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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).
Washout Period
The wash-out period will be between intervention 1 and intervention 2. 13 days in length.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
35 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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David Walega
Associate Professor, Chief, Division of Pain Medicine
Principal Investigators
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David R Walega, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University Feinberg School of Medicine
Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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STU86297
Identifier Type: -
Identifier Source: org_study_id
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