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

Last updated: March 19, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Chronic Pain

Treatment

Oxytocin

Placebo

Clinical Study ID

NCT04427709
IRB00066475
5P01NS119159-02
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.

  2. Generally in good health as determined by the Principal Investigator based on priormedical history, American Society of Anesthesiologists physical status 1, 2, or 3.

  3. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90mmHg) resting heart rate 45-100 beats per minute) without medication. For kneearthritis subjects, normal blood pressure or, for those with hypertension, pressurecontrolled with anti-hypertensives and with a resting heart rate 45-100 beats perminute.

  4. Female subjects of child-bearing potential and those < 1 year post-menopausal, mustbe 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 plusspermicidal jellies or cream), or total abstinence from heterosexual intercourse fora minimum of 1 full cycle before study drug administration.

Exclusion

Exclusion Criteria:

  1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®

  2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion ofthe Principal Investigator, would place the subject at increased risk (activegynecologic disease in which increased tone would be detrimental e.g., uterinefibroids with ongoing bleeding), compromise the subject's compliance with studyprocedures, or compromise the quality of the data

  3. Women who are pregnant (positive result for serum pregnancy test at screeningvisit), women who are currently nursing or lactating, women that have been pregnantwithin 2 years

  4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepinesor pain medications on a daily basis.

  5. Subjects with eye pathology, eye surgery, or taking topical eye medications, or anydisease process that would cause motor tremors or excessive eye movements.

Study Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Oxytocin
Phase: 2
Study Start date:
November 30, 2020
Estimated Completion Date:
January 31, 2026

Study Description

This is a single site study at Wake Forest School of Medicine. Healthy volunteers and patients with advanced knee arthritis being seen in the Orthopedic Clinic in consultation for potential total knee arthroplasty will be recruited after their doctor visit if the decision is made not to perform surgery at this time.

Study participants will come to the Pain Clinical Research Unit on 2 occasions. On these visits, they will receive an intramuscular (i.m.) injection of placebo or oxytocin, 25 micrograms (μg) (Pitocin®), obtained from the research pharmacy. The order in this cross-over study will be randomized and double blind, and the studies separated by at least 48 hours. Every 2.5 minutes beginning 20 minutes before injection and until 180 minutes after injection oscillation in pupil diameter at low frequency (hippus) will be obtained using an infrared pupilometer, in which they focus on a central point of gaze for 20 seconds. Hippus, a measure of parasympathetic output to the pupil and affected by central actions of oxytocin as described in preliminary data, will be calculated as the magnitude of power in the 0-0.25 Hertz (Hz) bin of the spectral analysis of pupil diameter, after removing blink and saccade artifacts. After 180 minutes the study participant will be discharged from the Pain Clinical Research Unit.

Connect with a study center

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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