Understanding Cognition, Oxytocin & Pain in Elders

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

Oxytocin (OT) is a mediator of endogenous analgesia in animal and human studies.

It had two arms (groups): Oxytocin Crossover Placebo Group (active comparator) and Placebo Crossover Oxytocin Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

The knee is the most commonly affected joint with pain being the primary symptom, negatively impacting physical, cognitive, and emotional functioning.

Symptomatic knee osteoarthritis has been traditionally attributed to peripheral mechanisms, but measures of joint damage only modestly account for the presence or severity of osteoarthritis-related pain.

The neuropeptide oxytocin has been recognized as a mediator of endogenous analgesia in animal and human studies.

However, little is known about the neurobiological mechanisms underlying oxytocin's pain-relieving properties.

Who Took Part

The registry lists 83 actual participants took part.

It was open to people of any sex aged from 45 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 25 exclusion criteria; among the exclusions: hypersensitivity to ot or vasopressin,; history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia,; on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication,.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-08-06 with completion listed for 2024-12-19.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in WOMAC Pain (0-20 Scale) (time frame: Baseline -> Week 4).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 83 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.