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Effects of Intranasal Oxytocin and Stress on Belief Updating

Plain-language guide to NCT03597893: not phased randomized trial of Oxytocin, 131 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03597893
Phase
not phased
Status
completed
Start
2016-12-27
Completion (planned or actual)
2017-08-15
Participants
131 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

In a randomized, double-blind, placebo controlled between-subjects design, healthy male volunteers receive intranasal oxytocin or placebo under stress or non-stress group prior belief updating task.

The Trier Social Stress Test (TSST) was used to induce psychosocial stress - this standardized technique enables a naturalistic exposure to a psychosocially stressful situation.

This method consists primarily of a public speaking in second language (English) and a mental arithmetic task performed in front of a panel.

Participants were not informed of the tasks prior to their recruitment.

Who Took Part

Enrollment: 131 actual participants took part.

It was open to men only aged from 18 years up to 40 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 1 exclusion criteria; among the exclusions: subjects with past or current psychiatric or neurological disorders.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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 2016-12-27 with completion listed for 2017-08-15.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: The updated probability estimation for negative events in the four experimental groups (time frame: 40~125 minutes after drug administration). The salivary cortisol level in four experimental groups (time frame: 40~125 minutes after drug administration). The correlation between personality traits and belief updating value in four experimental groups (time frame: 40~125 minutes after drug administration).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 131 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.