Using oxytocin to reduce pain in knee arthritis

Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

This study is testing whether oxytocin can help reduce pain in people with knee arthritis during a pain test.

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: NCT04431206 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of oxytocin, a naturally occurring hormone, on pain perception in individuals with knee osteoarthritis. Participants, including healthy volunteers and those with severe knee arthritis, will receive an intravenous infusion of oxytocin while undergoing a controlled pain test involving heated skin probes. The study aims to develop a pharmacodynamic model to understand how oxytocin alleviates pain and its movement in the body. Data will be analyzed by researchers at Stanford University to assess the efficacy of oxytocin in pain management.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 75 or individuals with severe knee arthritis who may require joint replacement.

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 a new approach to pain management for patients with knee osteoarthritis.

How similar studies have performed: While the use of oxytocin for pain management is an emerging area, similar studies have shown promising results in pain modulation, making this approach both novel and potentially impactful.

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 current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
6. Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI's, MAOI, or the recreational drug ecstasy.
7. Subjects with a known latex allergy.
8. Subjects with a pain score rating of 1 or less during the initial training session to a 5 minute heating of 45°C- 47 °C to the lower calf.

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 Osteoarthritis, Knee