Testing oxytocin's effects on pupil response in knee arthritis patients

Generate and Test the Reliability of a Pharmacodynamic Model of Oxytocin on Pupillary Hippus as a Measure of Central Nervous System Activity

This study tests if oxytocin injections can change how the pupils react in people with advanced knee arthritis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT04427709 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of oxytocin, administered via intramuscular injection, on the parasympathetic nervous system in patients with advanced knee arthritis. Participants will receive either oxytocin or a placebo in a randomized, double-blind, cross-over design. The primary measure will be the oscillation in pupil diameter, known as hippus, which reflects parasympathetic activity. The study aims to assess how oxytocin influences this response over a 180-minute observation period.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 75 with advanced knee arthritis who are not undergoing surgery.

Not a fit: Patients with significant comorbidities or those outside the specified age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into new treatment options for managing chronic pain in knee arthritis patients.

How similar studies have performed: While the specific application of oxytocin in this context is novel, there is preliminary data suggesting potential benefits of oxytocin on parasympathetic activity.

Eligibility criteria

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 prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3.
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.
4. 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.

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 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
3. 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
4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
5. Subjects with eye pathology, eye surgery, or taking topical eye medications, or any disease process that would cause motor tremors or excessive eye movements.

Where this trial is running

Winston-Salem, North Carolina

• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: James C Eisenach, MD — Wake Forest University Health Sciences
• Study coordinator: Regina Curry, RN

Conditions Chronic Pain; Osteoarthritis, Knee