Phase 4 N=22 Randomized Triple-blind Basic Science

Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)

Chronic Pain Due to Injury

Bottom Line

View on ClinicalTrials.gov: NCT04105998 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration — 1.61; 1.71 milliseconds^2 — p=0.64

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oxytocin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration	1.61; 1.71	0.64
PRIMARY Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration	0.98; 1.49	0.067
PRIMARY Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration	0.98; 1.49	0.067
PRIMARY Heart Rate Variability in the High Frequency Range	247; 381	0.111
PRIMARY Heart Rate Variability in the High Frequency Range	247; 381	0.111
PRIMARY Heart Rate Variability in the High Frequency Range	247; 381	0.111

Summary

The goal of this study is to test the effects of oxytocin on heart rate variability and pupil diameter, both of which have subtle effects on the activity rate of the autonomic nervous system.

Eligibility Criteria

Inclusion Criteria

Male or female > 18 and < 66 years of age,
Body Mass Index (BMI) <40
Generally in good health as determined by the Principal Investigator based on prior medical history
Normal blood pressure and resting heart rate without medication

Exclusion Criteria

Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk
Women who are pregnant (positive result for serum pregnancy test at screening visit),
Women who are currently nursing or lactating, women that have been pregnant within 2 years.
Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Previous eye surgery, eye medications, cataracts

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04105998). 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.