Oxytocin on Cold Water Task Performance and Recovery
Completed · Phase 2 · Has a placebo group
Conditions studied: Cold Exposure
In brief
Naval Special Warfare (NSW) operators are exposed to a variety of extreme environmental conditions and intense physical demands. 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. Biotechnologies that could mitigate the effects of cold as well as support physical recovery represent a significant unmet need for the NSW operational community. Oxytocin (OT) has a wide range of actions both locally in the brain and peripherally in the body including skeletal muscle. These peripheral effects can be mediated by classic ligand-receptor activation given the abundant expression of the oxytocin receptor in peripheral tissues, along with local expression of OT in peripheral tissues where it is likely to act in an autocrine manner. Exogenous OT via intranasal administration is FDA Investigational New Drug (IND)-approved and has been demonstrated as an easy and safe method to increase circulating OT concentrations that may augment actions on peripheral tissues.
Key facts
- Study ID
- NCT04738838
- Run by
- Florida Institute for Human and Machine Cognition
- People needed
- 17
- Starts
- 2022-05-20
- Expected to finish
- 2022-07-29
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older, up to 39. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Recreationally skilled swimmers
You may not qualify if…
- Smoking/vaping, a history of psychiatric disorders, safety requirements related to the oxytocin administration [hypersensitivity to oxytocin or vasopressin, history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia, on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication, or anti-inflammatory drugs, or muscle relaxants, low sodium and high osmolality levels, excessive smoking, excessive drinking, and significant nasal pathology.
Where it is running
- University of Florida — Gainesville, Florida, United States
- Florida Institute for Human and Machine Cognition — Pensacola, Florida, United States
Full record on ClinicalTrials.gov
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