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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04427709
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Pain
  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Oxytocin — DRUG
    Intramuscular injection of Oxytocin (Pitocin®)
  • Placebo — DRUG
    Intramuscular placebo injection

Study Details

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.

Key Dates

Start date
Nov 30, 2020
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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

Primary Outcome Measure

Fluctuation in Pupil Diameter (Hippus) -Pre drug administration [ Time Frame: Baseline before study drug administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157
Regina Curry, RN
[email protected]
336-716-4294
James C Eisenach, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Wake Forest Baptist Health· Winston-Salem, NC

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