Estimate Serum Oxytocin PD Range in the Periphery

What Was Tested

The trial (phase 2) is built around Oxytocin.

The main purpose of this study is to define the maximum effect oxytocin (naturally occurring hormone that is made in the brain) has on pain from a 5 minute heat probe applied to the skin and to get an estimate for the relationship between the amount of pain relief at different amounts of oxytocin in the blood.

It had four arms (groups): Oxytocin 4 picogram/millilitre (experimental), Oxytocin 16 picogram/millilitre (experimental), Oxytocin 64 picogram/millilitre (experimental) and Oxytocin 256 picogram/millilitre (experimental).

Oxytocin infused to maintain serum concentration of 4 picogram/millilitre.

Oxytocin infused to maintain serum concentration of 16 picogram/millilitre.

Oxytocin infused to maintain serum concentration of 64 picogram/millilitre.

The registry classes the interventions as drug.

More on the Plan

This is an unblinded, sequential study in which all participants will receive intravenous (IV) infusions of oxytocin in the same manner (except for safety reasons an adjustment at the highest level after review of the first 7 study participants as indicated in safety plan).

Study participants will come to the Clinical Research Unit (CRU) and two IVs inserted; one in each forearm.

Study participants will have an intravenous infusion of oxytocin at infusion rates that will result in a steady concentration of oxytocin in the blood for 15 minutes.

Who Took Part

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

How the Study Was Run

It was run as a non-randomized, sequential and open-label study.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2023-12 with completion listed for 2025-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Oxytocin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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