Oxytocin on Cold Water Task Performance and Recovery

What Was Tested

This registered phase 2 trial tested Oxytocin.

In addition to breathing high pressure gases at depth, prolonged cold water immersion and inadequate recovery from sustained physical exertion negatively impact individual and team performance.

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

The registry classes the interventions as drug.

More on the Plan

Cold water operators undergo an extensive and unique set of physical, physiological, and psychological stressors during a mission.

In-water transit may exceed 6 hours submerged in cold water, on rebreathers, and in a confined space.

Once the team has reached target, they must be at peak cognitive and physical readiness as they carry out their mission objective.

When the mission objective is complete, the operators undertake the lengthy return trip back to their deployed base.

Who Took Part

17 actual participants took part.

It was open to men only aged from 18 years up to 39 years.

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

Examples of who could join: Recreationally skilled swimmers.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, crossover and quadruple-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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2022-05-20 with completion listed for 2022-07-29.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Cognitive performance assessment score change (code substitution) (time frame: Within 3 hours post-treatment). Cognitive performance assessment score change (code substitution) (time frame: Within 3 hours post-treatment). Cognitive performance assessment score change (reaction time) (time frame: Within 3 hours post-treatment).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 17 people.

Its size is small, so on its own it can only give an early look.

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.