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NCT04738838 · ClinicalTrials.gov registry record · Phase 2
Oxytocin on Cold Water Task Performance and Recovery
A Phase 2 study of Cold Exposure, sponsored by Florida Institute for Human and Machine Cognition.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT04738838: Completed Phase 2 study of Cold Exposure, sponsored by Florida Institute for Human and Machine Cognition.
NCT04738838 is a Phase 2 study of Cold Exposure that has completed, run by Florida Institute for Human and Machine Cognition. The registered enrollment target is 17 participants, below the 60-participant average among 3 other Cold Exposure trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04738838, a Phase 2 study of Cold Exposure, has completed, sponsored by Florida Institute for Human and Machine Cognition.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Changes in code substitution scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in milliseconds for response time.
Conditions Studied
Interventions
- DRUG Oxytocin nasal spray
- DRUG Placebo nasal spray
Study Locations (2)
Florida
- University of Florida - Gainesville
- Florida Institute for Human and Machine Cognition - Pensacola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-05-20 |
| Est. Completion | 2022-07-29 |
| Phase | Phase 2 |
What the finished NCT04738838 record still lists
NCT04738838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 3 other Cold Exposure trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Cold Exposure appearing as the primary indexed condition, and to 2 interventions - of which Oxytocin nasal spray is the first listed.
NCT04738838 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04738838 about?
NCT04738838 is a clinical study titled "Oxytocin on Cold Water Task Performance and Recovery". 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...
What is the current status of trial NCT04738838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2022-05-20. Estimated completion is 2022-07-29.
What conditions does trial NCT04738838 study?
This clinical trial studies the following conditions: Cold Exposure.
What interventions are being tested in trial NCT04738838?
The interventions under investigation include: Oxytocin nasal spray (DRUG), Placebo nasal spray (DRUG).
Who is sponsoring clinical trial NCT04738838?
This trial is sponsored by Florida Institute for Human and Machine Cognition, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04738838 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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