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Hormone Therapy

Oxytocin nasal spray for Inflammation and Pain

Phase 2
Waitlist Available
Led By Marcas M Bamman, PhD
Research Sponsored by Florida Institute for Human and Machine Cognition
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in muscle stat3 phosphorylation from before to 24 hours after the resistance swim + hyperoxia
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is designed to study the effects of intranasal oxytocin on reducing stress and inflammation in Navy Seals.

Eligible Conditions
  • Inflammation and Pain
  • Inflammation
  • Stress Oxidative

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in muscle stat3 phosphorylation from before to 24 hours after the resistance swim + hyperoxia
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in muscle stat3 phosphorylation from before to 24 hours after the resistance swim + hyperoxia for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in blood oxidative stress via glutathione reductase activity
Change in muscle oxidative stress via glutathione reductase activity
Secondary study objectives
Change in systemic inflammation via serum concentration of interleukin-6 (IL-6)
Other study objectives
Change in maximum aerobic power (VO2max)
Change in muscle inflammation via muscle IL-6 pathway activity
Change in muscle soreness
+1 more

Side effects data

From 2019 Phase 1 & 2 trial • 23 Patients • NCT03119610
58%
Dizziness
42%
Allergic Rhinitis
42%
Nausea
33%
Headache
17%
Nasal Irritation
17%
Sore Throat
17%
Lightheaded
8%
Neck Pain
8%
Bruise related to biopsy
8%
Confusion
8%
Skin Rash
8%
Sinus Disorder
8%
Anorexia
8%
Throat itching
8%
Muscle Aches
8%
Upset stomach
8%
Migraine
8%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Nasal Spray
Oxytocin Nasal Spray

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oxytocin nasal sprayExperimental Treatment1 Intervention
4x per day (QID) intranasal treatment with oxytocin (48 IU per dose)
Group II: Placebo nasal sprayPlacebo Group1 Intervention
4x per day (QID) intranasal treatment with placebo (identical to oxytocin nose spray minus the oxytocin)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved

Find a Location

Who is running the clinical trial?

Translational Genomics Research InstituteOTHER
35 Previous Clinical Trials
106,989 Total Patients Enrolled
Florida Institute for Human and Machine CognitionLead Sponsor
5 Previous Clinical Trials
498 Total Patients Enrolled
Office of Naval Research (ONR)FED
14 Previous Clinical Trials
615 Total Patients Enrolled
~11 spots leftby Nov 2025
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