Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT04427709

Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity

Led by Wake Forest University Health Sciences · Updated on 2025-12-15

38

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this research is to evaluate the effects of oxytocin (naturally occurring hormone) given by an intramuscular (IM; into the muscle) injection, has on your parasympathetic nervous system. The parasympathetic nervous system is the part of the involuntary nervous system that is sometimes called the "rest and digest" system; the parasympathetic system conserves energy as it slightly slows the heart rate, increases intestinal and gland activity, and relaxes sphincter muscles in the gastrointestinal tract.

CONDITIONS

Official Title

Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged over 18 and under 75 years with Body Mass Index (BMI) under 40
  • Generally in good health as confirmed by the Principal Investigator
  • Healthy volunteers must have normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) and resting heart rate between 45-100 beats per minute without medication
  • Knee arthritis patients must have normal or controlled blood pressure and resting heart rate between 45-100 beats per minute
  • Female participants of child-bearing potential or less than 1 year post-menopausal must use highly effective birth control methods or abstain from heterosexual intercourse for at least one full cycle before study drug administration
Not Eligible

You will not qualify if you...

  • Allergy or significant reaction to any ingredient of Pitocin®
  • Any medical or surgical condition that increases risk or affects study compliance or data quality, including active gynecologic disease with uterine bleeding
  • Women who are pregnant, nursing, or have been pregnant within the last 2 years
  • Individuals with neuropathy, chronic pain, diabetes mellitus, or who take benzodiazepines or daily pain medications
  • Participants with eye problems, previous eye surgery, use of topical eye medications, or conditions causing tremors or excessive eye movements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

R

Regina Curry, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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