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

Who is this study for? Adult patients with Knee Osteoarthritis
What treatments are being studied? Oxytocin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

Locations
United States
North Carolina
Wake Forest Baptist Health
RECRUITING
Winston-salem
Contact Information
Primary
Regina Curry, RN
RECURRY@WAKEHEALTH.EDU
336-716-4294
Time Frame
Start Date: 2020-11-30
Estimated Completion Date: 2026-01
Participants
Target number of participants: 38
Treatments
Other: Oxytocin First, then Placebo
Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®) first then placebo injection.
Other: Placebo, Then Oxytocin
Subjects in this arm will receive Intramuscular placebo injection first then oxytocin injection
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov