The Effects of Oxytocin on Affective Touch

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

Moreover, associations with trait autism will be explored.

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

The registry classes the interventions as drug.

More on the Plan

A double-blind, within-subject, placebo controlled design will be employed in this study.

In a randomized-order a total of 40 healthy male subjects will receive oxytocin- and placebo-nasalspray (interval between the administration \> 2 weeks). 45 minutes after treatment subjects will be administered the touch-stimulation to the dorsal forearm by a trained experimenter (lengths: 8cm, rate 8cm/s).

After each block of stimulation, the subjects will be asked to rate their subjective experience of the touch.The neural basis of touch processing will be measured via simultaneously acquired fMRI.

Levels of trait autism will be assessed using the Autism Spectrum Quotient (ASQ) and related scales such as the Empathy Quotient (EQ), Liebowitz Social Anxiety Scale (LSAS), or the Sensory over Responsivity Scale (SOR) and Under Responsively Scale (URS).

Who Took Part

Enrollment: 50 actual participants took part.

It was open to men only aged from 18 years up to 30 years.

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

Examples of who could join: Healthy subjects without any past or present psychiatric or neurological disorders.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: history of brain injury medical or mental illness.

How the Study Was Run

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

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.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2017-08-28 with completion listed for 2018-01-31.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: brain function: neural activity during affective touch as assessed via BOLD fMRI (time frame: 45-90 minutes after treatment administration). Brain function: functional connectivity during affective touch as assessed via BOLD fMRI (time frame: 45-90 minutes after treatment administration).

It also tracked 7 secondary outcomes, for example Perceived affective quality of the touch, Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity, Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity, Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience, Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity and Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 50 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.