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

NCT04105998 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00060838
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain Due to Injury

Keywords

Healthy Volunteer; Oxytocin; Pupillometry

Outcome Measures

Primary Outcomes (6)

• Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration

  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.

  From 20 minutes before until study drug injection

• Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

  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.

  For 90 minutes after study drug administration

• Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

  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.

  For 120 minutes after study drug administration

• Heart Rate Variability in the High Frequency Range

  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.

  From 20 minutes before until study drug injection

• Heart Rate Variability in the High Frequency Range

  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.

  For 90 minutes after study drug administration

• Heart Rate Variability in the High Frequency Range

  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.

  For 120 minutes after study drug administration

Study Arms (2)

Oxytocin First, then Placebo

EXPERIMENTAL

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.

Drug: Oxytocin; Drug: Placebo

Placebo, Then Oxytocin

EXPERIMENTAL

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).

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

Oxytocin 10 IU

Also known as: Pitocin

Oxytocin First, then Placebo; Placebo, Then Oxytocin

Placebo DRUG

Placebo

Also known as: saline

Oxytocin First, then Placebo; Placebo, Then Oxytocin

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• Norman GJ, Cacioppo JT, Morris JS, Malarkey WB, Berntson GG, Devries AC. Oxytocin increases autonomic cardiac control: moderation by loneliness. Biol Psychol. 2011 Mar;86(3):174-80. doi: 10.1016/j.biopsycho.2010.11.006. Epub 2010 Nov 30.

  PMID: 21126557 BACKGROUND

• Turnbull PR, Irani N, Lim N, Phillips JR. Origins of Pupillary Hippus in the Autonomic Nervous System. Invest Ophthalmol Vis Sci. 2017 Jan 1;58(1):197-203. doi: 10.1167/iovs.16-20785.

  PMID: 28114580 BACKGROUND

MeSH Terms

Interventions

Oxytocin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest University School of Medicine

jimeisenach@gmail.com

336-716-4182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Investigator, and outcomes assessor will be blinded. The Research Pharmacist will prepare the study medication and hold the randomization.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded crossover treatment with oxytocin and placebo (saline)

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: October 24, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 10, 2022
• Results First Posted: November 10, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)