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Oxytocin and Non-verbal Communication

Plain-language guide to NCT03228901: phase 2 randomized trial of Oxytocin, 104 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03228901
Phase
phase 2
Status
completed
Start
2007-01
Completion (planned or actual)
2009-07
Participants
104 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Social Interaction
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Oxytocin.

In this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.

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

Matched nasal spray.

The registry classes the interventions as drug.

More on the Plan

Using Liu et al.'s (2012) dataset, the investigators seek to observe whether the administration of oxytocin modifies non-verbal communication with a stranger.

This dataset involves a conversation between two strangers that took place 45 minutes after drug administration.

While Liu et al. coded the video for markers of interpersonal distance (physical distance, eye contact, conversational intimacy), the investigators seek to analyse oxytocin's effects on non-verbal communication of affiliative and sexual cues (e.g., smiles, lip puckers).

Based on findings that oxytocin's effects depend on context, the investigators will explore these relationships as a function of the conversational context (where participants converse with each other using low-, medium-, and high-intimacy topics, or in an unstructured conversation).

Who Took Part

The registry lists 104 actual participants took part.

It was open to people of any sex.

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

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: history of epilepsy, severe depression, severe anxiety, or psychosis;; smoking more than 15 cigarettes a day;; addicted to illegal substances.

How the Study Was Run

The set-up was randomized, factorial and triple-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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2007-01 with completion listed for 2009-07.

It ran at 1 site in Australia.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Non-verbal communication (time frame: Measured in the interaction which commenced 45mins after drug administration).

It also tracked 1 secondary outcome, for example Ratings of the person participants interacted with.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 104 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.