NCT04732247

Oxytocin for Oxidative Stress and Inflammation

Completed Phase 2 Last updated 22 February 2024

What this trial tests

Phase 2 trial testing Oxytocin nasal spray in Oxidative Stress in 40 participants. Completed in 15 September 2023.

Timeline

1 February 2022

Primary endpoint
15 September 2023

15 September 2023

Quick facts

Lead sponsor	Florida Institute for Human and Machine Cognition
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	40
Start date	1 February 2022
Primary completion	15 September 2023
Estimated completion	15 September 2023
Sites	3 locations across United States

Drugs / interventions tested

• Oxytocin nasal spray — full drug profile →
• Placebo nasal spray — full drug profile →

Conditions studied

• Oxidative Stress — all drugs for Oxidative Stress →
• Inflammation — all drugs for Inflammation →

Sponsor

Florida Institute for Human and Machine Cognition

Who can join

Adults 18 to 39, male only, with Oxidative Stress or Inflammation. 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.

Due to the pleiotropic effects of OT on whole body metabolism, thermogenesis, stress responses, pain, mood, inflammation, appetite, glycemic control, skeletal homeostasis, and skeletal muscle repair and regeneration, there is increasing interest in the administration of exogenous OT for benefits to human health, performance and resilience. However, the biological mechanisms by which OT exerts tissue-specific effects (e.g., skeletal muscle) remain poorly understood, particularly in humans. This project is designed to significantly advance this understanding while testing the central hypothesis that intranasally administered OT attenuates systemic and skeletal muscle oxidative stress and inflammation induced by the combined stressor of resistance swim exercise and hyperoxia.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitreous Humor Proteome: Targeting Oxidative Stress, Inflammation, and Neurodegeneration in Vitreoretinal Diseases.
   Santos FM, Mesquita J, Castro-de-Sousa JP, Ciordia S, et al · · 2022 · cited 23× · PMID 35326156 · DOI 10.3390/antiox11030505
2. Exploring the Interplay of Antioxidants, Inflammation, and Oxidative Stress: Mechanisms, Therapeutic Potential, and Clinical Implications.
   Altanam SY, Darwish N, Bakillah A. · · 2025 · cited 4× · PMID 41002745 · DOI 10.3390/diseases13090309
3. Biological Connection of Psychological Stress and Polytrauma under Intensive Care: The Role of Oxytocin and Hydrogen Sulfide.
   Merz T, McCook O, Denoix N, Radermacher P, et al · · 2021 · cited 4× · PMID 34502097 · DOI 10.3390/ijms22179192