Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin for chronic pain: fibromyalgia & crps.

The goal of this clinical trial is to learn about oxytocin ( a naturally occurring hormone made in the brain that transmits messages) and the effects it may have on thermal heat pain after intravenous administration.

Participants will be asked to rate thermal heat temperatures before, during and after the intravenous infusion of oxytocin.

It had three arms (groups): Verbal Pain Score at 10 Minutes (other), Verbal Pain Score at 15 Minutes (other) and Verbal Pain Score at 20 Minutes (other).

The registry classes the interventions as drug.

Who Took Part

25 actual participants 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 8 exclusion criteria; among the exclusions: subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis; subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged qt interval; subjects with a known latex allergy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The chronic pain: fibromyalgia & crps participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

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.

It started in 2023-08-17 with completion listed for 2024-10-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Verbal Pain Score at the End of 5 Minutes of Skin Heating (time frame: 5-7 days).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 25 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.