Phase 4 N=20 Randomized Triple-blind Treatment

The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02550093 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. — 43.93; 43.0; 14.81; 13.33 degrees Celsius — p=.47

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Intervention 1 (Procedure); Washout Period (Behavioral); Intervention 2 (Procedure)
Age: Adult · 20+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius.	43.93; 43.0; 14.81; 13.33	.47
PRIMARY Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius.	43.60; 43.42; 15.68; 15.17	0.84
PRIMARY Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius.	43.94; 43.95; 15.41; 12.96	0.92
PRIMARY Mechanical Pain Threshold for Pain at Baseline in Grams.	194.90; 223.31	0.60
PRIMARY Mechanical Pain Threshold for Pain at 45 Minutes in Grams.	195.07; 197.49	0.68
PRIMARY Mechanical Pain Threshold for Pain at 90 Minutes in Grams.	198.76; 208.77	0.62
PRIMARY Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores.	2.90; 3.02	0.97
PRIMARY Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores.	2.58; 2.67	0.97
PRIMARY Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores.	2.53; 2.29	0.61
PRIMARY Thermal Wind-up Pain Assessment at Baseline	3.59; 3.15	0.71
PRIMARY Thermal Wind-up Pain at 45 Minutes	2.99; 2.85	0.74
PRIMARY Thermal Wind-up Pain at 90 Minutes	2.82; 2.63	0.75

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02550093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.