Overview

Oxytocin on Cold Water Task Performance and Recovery

Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Florida Institute for Human and Machine Cognition
Collaborators:
Office of Naval Research (ONR)
University of Florida
Treatments:
Oxytocin
Criteria
Inclusion Criteria:

- Recreationally skilled swimmers

Exclusion Criteria:

- 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.