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The Modulatory Effect of Oxytocin on Interoception

Plain-language guide to NCT03074409: not phased randomized trial of Oxytocin, 83 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03074409
Phase
not phased
Status
completed
Start
2017-03-02
Completion (planned or actual)
2017-09-06
Participants
83 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Interoception
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.

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

Intranasal administration of oxytocin.

Intranasal administration of the same ingredient except oxytocin.

The registry classes the interventions as drug.

More on the Plan

The present study will use a double-blind, between-subject, placebo-controlled design to investigate the modulatory effect of oxytocin on interoception and whether this effect will vary as a function of emotional valence.

In Experiment 1, subjects will perform a heartbeat detection task and the group differences between oxytocin and placebo groups of the interoceptive accuracy and neural activity in the core interoceptive network will be investigated.

In Experiment 2, subjects will be asked to watch emotional faces while perform the heartbeat detection task.

Investigators will examine whether oxytocin's effects on interoception will be varied as a function of different emotional valence.

Who Took Part

83 actual participants took part.

It was open to men only aged from 18 years up to 35 years.

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

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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 and investigator.

It started in 2017-03-02 with completion listed for 2017-09-06.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Heartbeat Detection (Interoception) Accuracy (time frame: 45 minutes after oxytocin/placebo treatment). Interoceptive Network Activity (time frame: 45 minutes after oxytocin/placebo treatment).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 83 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.