← Human Trials & Peer-Reviewed Studies

Effects of Oxytocin on Reinforcement Learning and Interoception

Plain-language guide to NCT05245708: not phased randomized trial of Oxytocin, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05245708
Phase
not phased
Status
completed
Start
2021-04-15
Completion (planned or actual)
2021-09-20
Participants
80 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

The main aim of the study is to investigate whether intranasal oxytocin has effects on reinforcement learning under dynamic environment and interoceptive processing based on behavioral and electroencephalogram (EEG) responses.

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

The registry classes the interventions as drug.

More on the Plan

A double-blinded, placebo-controled, between-subject design is employed in this study.

In a randomized order, a total of 80 healthy males are instructed to self-administrated intranasal spray of oxytocin or placebo.

(1) Participants first complete a probabilistic reward learning task 45 minutes after treatment with behavioral (response time and accuracy) and EEG data (ERP components such as FRN, ERN and P300) being collected during this task.

(2) A resting-state recording and a heartbeat counting task are conducted following the learning task with ECG and EEG data being collected.

Who Took Part

The registry lists 80 actual participants took part.

It was open to men only aged from 18 years up to 28 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 1 exclusion criteria; among the exclusions: history of brain injury medical or mental illness.

How the Study Was Run

It was run as a randomized, parallel-group and double-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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-04-15 with completion listed for 2021-09-20.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Behavioral index in the learning task: chioce accuracy (time frame: 45-65 minutes after treatment administration). Behavioral index in the heartbeat counting task: interoceptive accuracy (time frame: 65-75 minutes after treatment administration).

It also tracked 2 secondary outcomes, for example ERP components in the learning task: ERN, FRN, P300, N2pc and ERP components in the heartbeat counting task: heartbeat-evoked potential (HEP).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 80 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.