The Effects of Oxytocin Treatment on Social Touch

What Was Tested

This registered not phased trial tested Oxytocin.

It had three arms (groups): Intranasal oxytocin (experimental), Oral oxytocin (experimental) and Placebo (placebo comparator).

Participants will be randomly assigned to the administration of placebo.

The registry classes the interventions as drug.

More on the Plan

After each applied touch stimulation session, the subjects will be asked to rate their subjective experience of the touch including the perceived pleasantness, arousal, intensity and payment.

The neural basis of touch processing will be measured via simultaneously acquired fNIRS together with skin conductance responses and the electrocardiogram recording.

Blood samples will be taken before and after the treatment as well as after each run session to measure plasma oxytocin levels to explore the associations with primary outcome measure (the behavioral and neural measures of touch processing).

Mixed-measure analysis of variance (ANOVA) with treatment as between-subject factor and condition as within-subject factor will be used to investigate oxytocin effects on social touch processing.

Who Took Part

Enrollment: 180 actual participants took part.

It was open to people of any sex 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 and without any current psychotherapeutic medication.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

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

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 2021-09-01 with completion listed for 2022-03-01.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Neural index: fNIRS based measures of touch processing (time frame: 35-90 minutes after treatment administration). Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch (time frame: 50-90 minutes after treatment administration).

It also tracked 5 secondary outcomes, for example Plasma oxytocin concentration, Electrophysiological index: skin conductance responses (SCR), Electrophysiological index: heart rate variability (HRV), Questionnaire scores of autistic traits and Gender difference in the neural and behavioral index.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 180 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.