PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers

What Was Tested

The trial (phase 4) is built around Oxytocin for chronic pain: fibromyalgia & crps.

The primary goal of this protocol is to model change in oxytocin concentrations in plasma after intravenous (IV) administration.

Additional measurements will be performed on sensory function that could be influenced by oxytocin during later time periods when blood samples are widely separated by time.

It had 1 arm (groups): one (other).

The registry classes the interventions as drug.

More on the Plan

There are two measures which will assess two different aspects of sensory function.

MEASURE 1: Light Touch Frequency Threshold Light touch is subserved by a group of myelinated peripheral nerves with fast conduction in the Aβ range and which are capable of following high frequencies, being responsible for the sensation of vibration.

This capability of individual nerve fibers to respond with high frequency also underlies their ability to sense a light touch moving across the body surface as in brushing.

Oxytocin, when perfused around the neuronal cell bodies of these Aβ nerve fibers, partially restores their function, including their response to high frequency stimulation.

Who Took Part

11 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female \> 18 and \< 60 years of age, Body Mass Index (BMI) \<40. Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication.

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

Design: single-group and open-label.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-05-10 with completion listed for 2020-03-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Oxytocin Concentration (time frame: 2 minutes). Oxytocin Concentration (time frame: 5 minutes). Oxytocin Concentration (time frame: 10 minutes).

It also tracked 26 secondary outcomes, for example Light Touch Frequency Threshold, Light Touch Frequency Threshold, Light Touch Frequency Threshold, Light Touch Frequency Threshold, Light Touch Frequency Threshold and Light Touch Frequency Threshold.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Oxytocin in 11 people with chronic pain: fibromyalgia & crps.

Its size is small, so on its own it can only give an early look.

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

More context: the Oxytocin compound page, Chronic pain: fibromyalgia & CRPS research.