HealthyPhase 4NCT02550093

The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold

A Phase 4 study testing Intervention 1, Washout Period and Intervention 2 in people with Healthy, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Intervention 1, Washout Period and Intervention 2
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Apr 2015to Nov 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and females volunteers, English speaking

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study

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.

Conditions: Healthy
Being tested: Intervention 1, Washout Period, Intervention 2
Keywords: Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention 1Procedure or surgery
Also called Day 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 PeriodBehavioural
The wash-out period will be between intervention 1 and intervention 2. 13 days in length.
Intervention 2Procedure or surgery
Also called Day 14
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).

Study groups in NCT02550093
Study group	Role	What they receive
Oxytocin, then Normal Saline	Experimental	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). Receives: Procedure: Intervention 1; Behavioral: Washout Period; Procedure: Intervention 2
Normal Saline, then Oxytocin	Experimental	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). Receives: Procedure: Intervention 1; Behavioral: Washout Period; Procedure: Intervention 2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: 45 minutes
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.
Measured: 90 minutes
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.
Measured: Baseline
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.
Measured: 45 minutes
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.
Measured: 90 minutes
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).
Measured: Baseline
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).
Measured: 45 minutes
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).
Measured: 90 minutes
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).
Measured: Baseline
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).
Measured: 45 minutes
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).
Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Nov 2016

First posted15 Sep 2015 (estimated)
Study startApr 2015
Primary completionAug 2015
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02550093
Sponsor's protocol ID: STU86297
Status last verified: May 2022
First submitted: 16 Apr 2015
Last updated: 16 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 23055480
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.
PubMed 16223754
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.
PubMed 21429671
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.
PubMed 23887343
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.
PubMed 23375440
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.
PubMed 19102589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study
ClinicalTrials.gov ID: NCT02550093
Acronym / sponsor ID: STU86297
Conditions: Healthy
Keywords: Volunteers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Apr 2015
Primary completion: Aug 2015 (actual)
Study completion: Nov 2016 (actual)
First posted: 15 Sep 2015 (estimated)
Results: Posted 16 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oxytocin, then Normal Saline	Experimental	Procedure: Intervention 1, Behavioral: Washout Period, Procedure: Intervention 2Each 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).
Normal Saline, then Oxytocin	Experimental	Procedure: Intervention 1, Behavioral: Washout Period, Procedure: Intervention 2Each 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).

Who may qualify

Ages: 20 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy males and females volunteers, English speaking

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intervention 1Also: Day 1Each 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).	Procedure or surgery	Normal Saline, then Oxytocin, Oxytocin, then Normal Saline
Washout PeriodThe wash-out period will be between intervention 1 and intervention 2. 13 days in length.	Behavioural	Normal Saline, then Oxytocin, Oxytocin, then Normal Saline
Intervention 2Also: Day 14Each 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).	Procedure or surgery	Normal Saline, then Oxytocin, Oxytocin, then Normal Saline

Primary outcome

Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius.
Time frame: Baseline
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.
Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius.
Time frame: 45 minutes
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.
Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius.
Time frame: 90 minutes
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.
Mechanical Pain Threshold for Pain at Baseline in Grams.
Time frame: Baseline
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.
Mechanical Pain Threshold for Pain at 45 Minutes in Grams.
Time frame: 45 minutes
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.
Mechanical Pain Threshold for Pain at 90 Minutes in Grams.
Time frame: 90 minutes
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.
Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores.
Time frame: Baseline
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).
Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores.
Time frame: 45 minutes
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).
Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores.
Time frame: 90 minutes
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).
Thermal Wind-up Pain Assessment at Baseline
Time frame: 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).
Thermal Wind-up Pain at 45 Minutes
Time frame: 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).
Thermal Wind-up Pain at 90 Minutes
Time frame: 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).

Results and safety

Results posted to the registry on 16 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxytocin, Then Normal Saline	10	10
Normal Saline, Then Oxytocin	10	10

Primary outcome: Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius.

Time frame: Baseline. Mean (Standard Deviation). Unit: degrees Celsius

Measure	Oxytocin n = 20	Normal Saline n = 20
Heat	43.93 (4.18)	43.0 (4.34)
Cold	14.81 (11.10)	13.33 (10.51)

Oxytocin vs Normal Saline: p = .47, Wilcoxon (Mann-Whitney)
Oxytocin vs Normal Saline: p = 0.70, Wilcoxon (Mann-Whitney)

Primary outcome: Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius.

Time frame: 45 minutes. Mean (Standard Deviation). Unit: degrees Celsius

Measure	Oxytocin n = 20	Normal Saline n = 20
Heat	43.60 (3.68)	43.42 (3.98)
Cold	15.68 (10.60)	15.17 (10.88)

Oxytocin vs Normal Saline: p = 0.84, Wilcoxon (Mann-Whitney)
Oxytocin vs Normal Saline: p = 0.95, Wilcoxon (Mann-Whitney)

Primary outcome: Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius.

Time frame: 90 minutes. Mean (Standard Deviation). Unit: degrees Celsius

Measure	Oxytocin n = 20	Normal Saline n = 20
Heat	43.94 (3.97)	43.95 (3.80)
Cold	15.41 (11.24)	12.96 (11.38)

Oxytocin vs Normal Saline: p = 0.92, Wilcoxon (Mann-Whitney)
Oxytocin vs Normal Saline: p = 0.63, Wilcoxon (Mann-Whitney)

Primary outcome: Mechanical Pain Threshold for Pain at Baseline in Grams.

Time frame: Baseline. Mean (Standard Deviation). Unit: Grams

Measure	Oxytocin n = 20	Normal Saline n = 20
Value	194.90 (117.52)	223.31 (149.56)

Oxytocin vs Normal Saline: p = 0.60, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: 24hrs after intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxytocin	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Normal Saline	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): Though we used the same method of intranasal administration as preceding studies, it is possible that the oxytocin did not reach peak levels at the time of the testing or was not absorbed. We did not assess plasma levels of oxytocin to assess whether absorption occurred and was consistent among all participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23055480Yamasue 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.
Background: PubMed 16223754Fewtrell 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.
Background: PubMed 21429671MacDonald 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.
Background: PubMed 23887343Rash 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.
Background: PubMed 23375440Wang 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.
Background: PubMed 19102589Singer 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David R Walega, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intervention 1, Washout Period and Intervention 2 in people with Healthy, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02550093, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.