CompletedPhase 4

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

United States22 participantsStarted 2019-10-24

Plain-language 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.

Who can participate

Age range

18 Years – 66 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration

Timeframe: From 20 minutes before until study drug injection

Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

Timeframe: For 90 minutes after study drug administration

Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

Timeframe: For 120 minutes after study drug administration

Heart Rate Variability in the High Frequency Range

Timeframe: From 20 minutes before until study drug injection

Heart Rate Variability in the High Frequency Range

Timeframe: For 90 minutes after study drug administration

Heart Rate Variability in the High Frequency Range

Timeframe: For 120 minutes after study drug administration

Trial details

NCT IDNCT04105998

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-01

Results submitted2022-10-14

View on ClinicalTrials.gov More Chronic Pain Due to Injury trials

Who can participate

Age range

18 Years – 66 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration

Timeframe: From 20 minutes before until study drug injection

Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

Timeframe: For 90 minutes after study drug administration

Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration

Timeframe: For 120 minutes after study drug administration

Heart Rate Variability in the High Frequency Range

Timeframe: From 20 minutes before until study drug injection

Heart Rate Variability in the High Frequency Range

Timeframe: For 90 minutes after study drug administration

Heart Rate Variability in the High Frequency Range

Timeframe: For 120 minutes after study drug administration