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

NCT04427709 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IRB000664755P01NS119159-02
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Pain; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Fluctuation in Pupil Diameter (Hippus) -Pre drug administration

  Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter. One measure of coefficient of variation at each time period. It is calculated by the amount of variability in a window of time. Every 2.5 minutes beginning 20 minutes before the intramuscular injection of placebo or oxytocin, 25 micrograms.

  Baseline before 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. One measure of coefficient of variation at each time period. It is calculated by the amount of variability in a window of time. Every 2.5 minutes for 180 after intramuscular injection of placebo or oxytocin, 25 micrograms.

  up to 180 minutes after study drug administration

Study Arms (2)

Oxytocin First, then Placebo

OTHER

Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®) first then placebo injection.

Drug: Oxytocin; Drug: Placebo

Placebo, Then Oxytocin

OTHER

Subjects in this arm will receive Intramuscular placebo injection first then oxytocin injection

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

Intramuscular injection of Oxytocin (Pitocin®)

Also known as: Pitocin

Oxytocin First, then Placebo; Placebo, Then Oxytocin

Placebo DRUG

Intramuscular placebo injection

Oxytocin First, then Placebo; Placebo, Then Oxytocin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.
• Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3.
• For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
• Female subjects of child-bearing potential and those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.

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 (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
• 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
• Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
• Subjects with eye pathology, eye surgery, or taking topical eye medications, or any disease process that would cause motor tremors or excessive eye movements.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis, Knee

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Curry, RN

CONTACT

336-716-4294; RECURRY@WAKEHEALTH.EDU

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be maintained by the research pharmacist and by an independent individual not affiliated with the data collection or outcome evaluation
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, crossover study. Each participant will receive Oxytocin 25 micrograms and placebo via intramuscular injection

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: November 30, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)