Last reviewed · How we verify
NCT04738838
Oxytocin on Cold Water Task Performance and Recovery
Phase 2 trial testing Oxytocin nasal spray in Cold Exposure in 17 participants. Completed in 29 July 2022.
29 July 2022
Quick facts
| Lead sponsor | Florida Institute for Human and Machine Cognition |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 17 |
| Start date | 20 May 2022 |
| Primary completion | 29 July 2022 |
| Estimated completion | 29 July 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Oxytocin nasal spray — full drug profile →
- Placebo nasal spray — full drug profile →
Conditions studied
- Cold Exposure — all drugs for Cold Exposure →
Sponsor
Florida Institute for Human and Machine Cognition
Who can join
Adults 18 to 39, male only, with Cold Exposure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04738838
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oxytocin nasal spray
Trials testing the same drug.
- NCT07162584 — Oxytocin and Human Defensive Responses in a Dynamic Situation · NA · recruiting
- NCT06194851 — Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD · Phase 2 · recruiting
- NCT05934812 — Intranasal Oxytocin in Youth With Autism · Phase 2 · not yet recruiting
- NCT06881810 — Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment · Phase 2 · recruiting
- NCT06332066 — Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness · Phase 1 · unknown
Other recruiting trials for Cold Exposure
Currently open trials in the same condition.
- NCT07489690 — Energy Dense Fueling for Cold-Weather Operations · NA · recruiting
- NCT06978777 — Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity · NA · recruiting
- NCT06424132 — Thermogenic Silencer Regulatory Factors in Humans · NA · active not recruiting
- NCT03541096 — Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT). · NA · active not recruiting
Other Florida Institute for Human and Machine Cognition trials
Trials by the same sponsor.
- NCT06591780 — Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy · NA · recruiting
- NCT06507189 — Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults (M3AX) · NA · recruiting
- NCT07065864 — Ketone Esters for Optimization of Operator Performance in Hypoxia · NA · completed
- NCT04732247 — Oxytocin for Oxidative Stress and Inflammation · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04738838 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Florida Institute for Human and Machine Cognition
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04738838.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing