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Oxytocin on Cold Water Task Performance and Recovery

NCT04738838 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Cold Exposure

Interventions

DRUG

Oxytocin nasal spray

Intranasal treatment with oxytocin via nasal spray (48 IU per dose)

DRUG

Placebo nasal spray

Intranasal treatment with placebo via nasal spray

Sponsors & Collaborators

  • Office of Naval Research (ONR)

    collaborator FED

  • University of Florida

    collaborator OTHER

  • Florida Institute for Human and Machine Cognition

    lead OTHER

Principal Investigators

  • Marcas Bamman, Ph.D. · Florida Institute for Human and Machine Cognition

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2022-07-29
Completion
2022-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738838 on ClinicalTrials.gov