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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT04105998 (opens ClinicalTrials.gov in a new tab)Other idIRB00060838
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Overview

Status
Completed
Phase
Phase 4
Enrollment
22 participants (actual)
Sponsor
Wake Forest University Health Sciences · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
24 Oct 2019
Primary completion
1 Nov 2021
Completion
1 Nov 2021
First posted
26 Sept 2019
Last update posted
10 Nov 2022
Conditions
Chronic Pain Due to Injury

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 4

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

    NCT04105998

    24 Oct 2019 to 1 Nov 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin First, then Placebo

    Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®), 10 International Units (IU) at the first visit. Then at the next visit, they will receive Intramuscular injection of (1 milliliter) saline.

  • Experimental

    Placebo, Then Oxytocin

    Subjects in this arm will receive intramuscular injection of (1 milliliter) saline at the first visit. Then at the next visit, they will receive Intramuscular injection of Oxytocin (Pitocin®), 10 International Units (IU).

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration

    Time frame · From 20 minutes before until study drug injection

    Registry description

    Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter in the .1-2 Hz range, termed hippus. Pupil measurements will be made for 20 seconds every 5 minutes for 20 minutes. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.

  2. Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

    Time frame · For 90 minutes after study drug administration

    Registry description

    Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter in the .1-2 Hz range, termed hippus. Pupil measurements will be made for 20 seconds every 5 minutes until 90 minutes after study drug administration. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.

  3. Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

    Time frame · For 120 minutes after study drug administration

    Registry description

    Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter in the .1-2 Hz range, termed hippus. Pupil measurements will be made for 20 seconds every 5 minutes until 120 minutes after study drug administration. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.

  4. Heart Rate Variability in the High Frequency Range

    Time frame · From 20 minutes before until study drug injection

    Registry description

    Magnitude of peak power in the 0.12-0.40 Hz frequency range of the Fast Fourier Transform of heart rate. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.

  5. Heart Rate Variability in the High Frequency Range

    Time frame · For 90 minutes after study drug administration

    Registry description

    Magnitude of peak power in the 0.12-0.40 Hz frequency range of the Fast Fourier Transform of heart rate. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.

  6. Heart Rate Variability in the High Frequency Range

    Time frame · For 120 minutes after study drug administration

    Registry description

    Magnitude of peak power in the 0.12-0.40 Hz frequency range of the Fast Fourier Transform of heart rate. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From 20 minutes before until study drug injection

Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration

GroupValue (milliseconds^2)Spread
Oxytocin1.611.20
Placebo1.711.26
Primary outcomeMean· For 90 minutes after study drug administration

Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

GroupValue (milliseconds^2)Spread
Oxytocin1.340.56
Placebo1.520.68
Primary outcomeMean· For 120 minutes after study drug administration

Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

GroupValue (milliseconds^2)Spread
Oxytocin0.980.54
Placebo1.491.39
Primary outcomeMean· From 20 minutes before until study drug injection

Heart Rate Variability in the High Frequency Range

GroupValue (milliseconds^2)Spread
Oxytocin182151
Placebo253296
Primary outcomeMean· For 90 minutes after study drug administration

Heart Rate Variability in the High Frequency Range

GroupValue (milliseconds^2)Spread
Oxytocin183158
Placebo300296
Primary outcomeMean· For 120 minutes after study drug administration

Heart Rate Variability in the High Frequency Range

GroupValue (milliseconds^2)Spread
Oxytocin247216
Placebo381273

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinParticipant received intravenous oxytocin, 10 International Units (IU) on study day 1 or 20 / 220 / 220 / 22
PlaceboParticipant received intravenous placebo on study day 1 or 20 / 220 / 220 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2011

Oxytocin increases autonomic cardiac control: moderation by loneliness.

Norman et al. 2011Biological psychologycited by 163

PMID 21126557DOI 10.1016/j.biopsycho.2010.11.006PUB-21126557

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 66 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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