Effects of Oxytocin Administered Orally Using a Medicated Lollipop on Peripheral Concentrations and Attention

What Was Tested

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

It had two arms (groups): oral oxytocin (experimental) and oral lollipop with placebo (placebo comparator).

Placebo orally (identical ingredients, except the active agent).

The registry classes the interventions as drug.

More on the Plan

Subjects will sit quietly and relax in between blood samples.

After the second blood sample, subjects will be positioned sitting in front of an eye-tracking machine and briefly practicing the anti-saccade task.

Subjects will then perform the full anti-saccade eye-tracking task, which includes both social (emotional faces - angry, fear, happy, sad, and neutral) and non-social (oval shapes or houses) stimuli (similar to previous studies using intranasal -see NCT03486925 and NCT04493515).

After the task, subjects will be asked to guess which treatment they received, and their ability to do so analyzed using chi-squared.

Who Took Part

Enrollment: 72 planned participants were the target.

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 4 exclusion criteria; among the exclusions: history of brain injury; head trauma; substance abuse.

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.

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, investigator and outcomes assessor.

It started in 2022-04-01 with completion listed for 2022-07-30.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Oral oxytocin effect on error rates of saccade/anti-saccade to social (faces) and non-social (shape) cues between the oxytocin and placebo groups (time frame: 45minutes ~ 100 minutes after oral lollipop). Oral oxytocin effect on latencies (in milliseconds) of saccade/anti-saccade to social (faces) and non-social (shape) cues between the oxytocin and placebo groups (time frame: 45minutes ~ 100 minutes after oral lollipop).

It also tracked 7 secondary outcomes, for example Plasma oxytocin concentrations (pg/ml) before (basal) and 30 minutes after oral oxytocin or placebo administration, Change of Mood as assessed by the Positive Affect Negative Affect Scale (PANAS) before and after the experiment in two treatment groups, Change of state anxiety as assessed by the State-Trait Anxiety Inventory (STAI) before and after the experiment in two treatment groups, Comparison between the effects of oxytocin administered intranasally, lingually, and orally on anti-saccade errors (%) by mixed ANOVA and Comparison between the effects of oxytocin administered intranasally, lingually, and orally on latencies in milliseconds by mixed ANOVA.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 72 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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