Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

What Was Tested

This registered phase 2 trial tested Oxytocin.

This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain).

Each study participant will have an IV catheter placed.

It had four arms (groups): Verbal pain score at 2 minutes (other), Verbal pain score at 5 minutes (other), Verbal pain score at 7 minutes (other) and Verbal pain score at 10 minutes (other).

Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes.

Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes.

Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes.

The registry classes the interventions as drug.

More on the Plan

Study participants will come to the Clinical Research Unit (CRU) and one intravenous (IV) catheter will be inserted in the forearm for oxytocin infusion.

Participants in this study will receive oxytocin at a steady rate for 30 minutes.

For this Investigators will place a probe on the skin and heat it to 113 - 117 degrees for 5 minutes.

Study participants will score any pain they feel on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale.

Who Took Part

Enrollment: 7 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.

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.

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 2020-11-04 with completion listed for 2020-11-25.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): First Verbal Pain Score After Beginning IV Oxytocin Infusion (time frame: 2-10 minutes after starting oxytocin infusion, depending on Arm). Second Verbal Pain Score After Beginning IV Oxytocin Infusion (time frame: 17-25 minutes after starting oxytocin infusion, depending on Arm). Third Verbal Pain Score After Beginning IV Oxytocin Infusion (time frame: 32-40 minutes after starting oxytocin infusion, depending on Arm).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 7 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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