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Oxytocin and the Processing of Social Stress-Associated Chemosignals

Plain-language guide to NCT03265899: phase 1 randomized trial of Oxytocin, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03265899
Phase
phase 1
Status
completed
Start
2015-07-01
Completion (planned or actual)
2016-11-30
Participants
60 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy Volunteers
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Oxytocin.

The purpose of this study is to determine whether oxytocin modulates the processing of stress-associated chemosignals and which substrates are involved.

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

Sodium chloride solution, intranasal application 30 min prior to the experiment.

The registry classes the interventions as drug.

More on the Plan

Social transmission of stress and fear is not restricted to visual or auditory cues, but extends to the olfactory domain, a phylogenetically more ancient sense.

The neuropeptide oxytocin (OXT) exerts anxiolytic and anti-stress effects in visual and auditory modalities, however, it still elusive whether OXT also modulates the processing of stress-associated chemosignals.

The investigators expect that OXT selectively diminishes chemosensory-induced behavioral biases and neural responses to stress-related odors.

Who Took Part

60 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 2 inclusion and 7 exclusion criteria; among the exclusions: current or past psychiatric disease; current or past physical illness; psychoactive medication.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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 2015-07-01 with completion listed for 2016-11-30.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful) (time frame: 30 min after nasal spray administration). Response time for facial stimuli ratings (time frame: 30 min after nasal spray administration). Blood-oxygen-level dependent signal in response to chemosensory cues (time frame: 30 minutes after nasal spray administration).

It also tracked 3 secondary outcomes, for example Questionnaire measurement of mood (PANAS), Saliva oxytocin concentrations and Questionnaire measurement of anxiety (STAI).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 60 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.