Effects of Intranasal Oxytocin Administration on Social Influence Effects on Pain

What Was Tested

The trial (phase 1) is built around Oxytocin.

This experiment will explore the joint effects of social information, social support, associative learning, and oxytocin on the development of placebo analgesia.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

Each participant will undergo pain tasks after self-administration of oxytocin.

Each participant will undergo pain tasks after self-administration of placebo.

The registry classes the interventions as drug.

More on the Plan

However, when the same 'conditioning' was performed without the verbal explanation for why the treatment seemed to work, robust placebo effects were created.

Conceptual processes appear to be critical.

Learning by experience also seems to be critical.

The investigators propose another view: Both processes are critical, and they interact.

Who Took Part

51 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Subject is a volunteer between 18 and 40 years of age. If female, subject is non-lactating, not pregnant, and using a reliable contraception method. Subject is able to read and speak English. Subject is able and willing to provide written informed consent. Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: chronic pain; do not have the ability to tolerate heat pain applied to the forearm; have temporary abnormal levels of pain.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-06-21 with completion listed for 2019-03-05.

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: Change in pain expectation rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo. Change in pain rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo. Change in pain unpleasantness rating score during hand holding and control conditions made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 51 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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