Comparison of Intranasal Oxytocin Effects Using Co-administration With a Vasoconstrictor

What Was Tested

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

Primary outcomes of the randomized placebo-controlled double-blind experiment are blood oxytocin concentration and oxytocin-associated responses in central and peripheral systems.

It had three arms (groups): vasoconstrictor + intranasal oxytocin group (experimental), vasoconstrictor's placebo + intranasal oxytocin group (active comparator) and vasoconstrictor + intranasal oxytocin placebo group (placebo comparator).

Subjects receive the vasoconstrictor followed by oxytocin.

Subjects receive the vasoconstrictor's placebo followed by oxytocin.

Subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo.

The registry classes the interventions as drug.

Who Took Part

96 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 past or current psychiatric or neurological disorders.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: history of head injury; medical or psychiatric illness.

How the Study Was Run

It was run as a randomized, parallel-group and double-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 and investigator.

It started in 2019-03-02 with completion listed for 2021-06-18.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: blood oxytocin concentration (time frame: 2 hours). resting EEG time-frequency (time frame: 2 hours).

It also tracked 3 secondary outcomes, for example heartrate, skin conductance and gastrointestinal activity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 96 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.