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Oxytocin's Effect on Attention Training

Plain-language guide to NCT03128242: not phased randomized trial of Oxytocin, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03128242
Phase
not phased
Status
status unknown
Start
2016-11-25
Completion (planned or actual)
2018-12-30
Participants
60 (estimated)
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.

This study aims to investigate oxytocin's effect on attentional bias training.

Healthy participants will undergo a dot-probe task-based training to direct their attention away from negative stimuli (as compared to neutral).

Effects of the training will be assessed using an eye-tracking anti-saccade task.

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

Oxytocin treatment.

Placebo treatment.

The registry classes the interventions as drug.

More on the Plan

In this study, a dot-probe task will be used to examine if subjects show an attentional bias towards negative stimuli and whether the bias can be modified using a subsequent attentional bias training.

During this training participants learn to direct their attention away from threatening stimuli.

In a between-subject placebo controlled design participants will receive either intranasal oxytocin or placebo before the training to examine whether oxytocin could facilitate the effects of the attention training.

Effects of the training and of oxytocin on the training will be assessed by means of an eye-tracking anti-saccade task.

Who Took Part

Enrollment: 60 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: Male participants with elevated trait anxiety (\> 45 scores as assessed with the State and Trait Anxiety Inventory, Spielberger, 1983). Without past or current psychiatric or neurological disorders.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: history of head injury; medical or psychiatric illness; smoking or drinking 24 hours before the experiment.

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 2016-11-25 with completion listed for 2018-12-30.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Reaction time (RT) difference - oxytocin effects (time frame: Before drug administration (pre-treatment baseline) and 55 minutes after drug administration). Reaction time (RT) difference - training effects (time frame: Before drug administration - 55-90 minutes after drug administration). Saccade latency difference - training effects (time frame: Before drug administration - 55-90 minutes after drug administration).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 60 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.

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.