Status:
RECRUITING
Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Chronic Pain
Osteoarthritis, Knee
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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....
Detailed 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04427709
Start Date
November 30 2020
End Date
December 1 2026
Last Update
December 15 2025
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157