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Differential Effects of Oral and Intranasal Oxytocin on Attention Control

Plain-language guide to NCT04815395: not phased randomized trial of Oxytocin, 151 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04815395
Phase
not phased
Status
completed
Start
2017-12-19
Completion (planned or actual)
2021-01-01
Participants
151 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin.

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

Placebo orally.

The registry classes the interventions as drug.

More on the Plan

To this end data from subjects who underwent intranasal oxytocin administration (n = 33, NCT03486925) will be compared with data from subjects who underwent oral oxytocin or placebo administration (n = 36, or 37 respectively; NCT04493515).

Who Took Part

151 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: Male, healthy participants.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: previous or current medical, psychiatric, neurological disorder; regular medication; use of any psychoactive substances in the 24 hours before experiment.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2017-12-19 with completion listed for 2021-01-01.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Differential effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli (time frame: 45 minutes - 100 minutes after treatment). Differential effects of intranasal and oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli (time frame: 45 minutes - 100 minutes after treatment).

It also tracked 2 secondary outcomes, for example Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 151 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.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.