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Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

Plain-language guide to NCT05823441: phase 4 randomized trial of Oxytocin, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05823441
Phase
phase 4
Status
completed
Start
2023-06-03
Completion (planned or actual)
2024-01-21
Participants
120 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Oxytocin; Pain; Empathy; Social Familiarity; Analgesia
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Oxytocin.

This study recruited healthy volunteers and randomly divided them into four groups.

They inhaled oxytocin or saline, and watched a pain test video with photos of acquaintances or strangers, respectively, to test whether their feelings of the same thermal pain stimulus had changed.

It had four arms (groups): OS group (placebo comparator), PS group (placebo comparator), OA group (experimental) and PA group (placebo comparator).

Half an hour after the volunteers inhaled the same amount of saline spray, they watched the pre recorded video (with pictures and introductions of strangers attached) and received a pain test.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 120 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: during pregnancy;; have participated in any research related to pain;; sleep disorders;.

How the Study Was Run

Design: randomized, factorial and quadruple-blind.

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

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

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

It started in 2023-06-03 with completion listed for 2024-01-21.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: NRS score (time frame: Half an hour after inhaling spray).

It also tracked 8 secondary outcomes, for example EEG, Brief Profile Of Mood States, Beck Depression Inventory, WLEIS-C, STAI and BES-C.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 120 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.