Faces: Choices Study

What Was Tested

The trial (phase 2, phase 3) is built around Oxytocin.

Thus, age-related changes in the OXT system may underlie differences between young and older adults in socioemotional functioning.

Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging.

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

The registry classes the interventions as drug.

More on the Plan

Overview: This study has three parts: An initial screening visit and two study visits.

The blood test will also be used to determine the level of oxytocin, testosterone, and estrogen in the participant's body that occur normally. * The participant will then have a brief consultation with a licensed physician, to go over their medical review.

This will not be a clinical doctor visit for routine medical care, but a visit to confirm the participant's healthy medical status to participate in the research study.

The participant will be assigned by chance, much like the flip of a coin, to receive either the oxytocin or the placebo during the first study visit.

Who Took Part

It was open to men only aged from 18 years up to 85 years.

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

Examples of who could join: Between the ages of 18-33 (for the younger adults) and 60-85 (for the older adults).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: severe claustrophobia; currently on vasoconstrictors, pseudoephedrine or antidiuretic medication; surgery on the brain or any prior serious brain damage or disease.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2019-01-01 with completion listed for 2019-08-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: The change in choices task between baseline and at week 2 (time frame: Change between baseline and at week 2).

It also tracked 6 secondary outcomes, for example The change in General Trust Measure Questionnaire between baseline and at week 2, The change in Empathy Quotient Questionnaire between baseline and at week 2, The change in Trait Meta-Mood Scale Questionnaire between baseline and at week 2, The change in Inclusion of Community in the Self Scale Questionnaire between baseline and at week 2, Gift basket task and Donation task.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.