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Hormone Therapy

Oxytocin nasal spray for Inflammation

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

Study Summary

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

Eligible Conditions
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in blood oxidative stress via glutathione reductase activity
Change in muscle oxidative stress via glutathione reductase activity
Secondary outcome measures
Change in systemic inflammation via serum concentration of interleukin-6 (IL-6)
Other outcome measures
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

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
4 Previous Clinical Trials
248 Total Patients Enrolled
Office of Naval Research (ONR)FED
14 Previous Clinical Trials
682 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial taking place in several hospitals across North America?

"There are 4 recruiting patients for this clinical trial including Translational Genomics Research Institute in Phoenix, University of Florida in Gainesville, and Florida Institute for Human and Machine Cognition in Pensacola. Other locations interested in participating are also being considered."

Answered by AI

Does this experiment have an age requirement?

"Eligibility for this particular clinical study necessitates that patients are aged 18-39. In contrast, there are 37 other trials available for minors and 329 trials catering to an older demographic."

Answered by AI

Could you detail potential risks associated with Oxytocin nasal spray?

"Our team at Power has rated the safety of Oxytocin nasal spray as a 2. This is because it is a Phase 2 trial, which means that there is some data supporting its safety but none supporting its efficacy."

Answered by AI

How many individuals are allowed to participate in this experiment?

"As of now, this trial has ceased searching for new participants. The study was first posted on July 1st, 2021 and updated last on January 26th, 2021. If you're looking for other trials, there are presently 399 studies actively enrolling patients with inflammation and 57 trials for Oxytocin nasal spray that need participants."

Answered by AI

Are people still being accepted into this clinical trial?

"This particular trial is not looking for new patients, as per the listing on clinicaltrials.gov. The study was first announced on July 1st 2021 but has not been updated since January 26th of the same year. There are 456 other trials with open recruitment at this time."

Answered by AI

Who qualifies to take part in this particular experiment?

"Up to 40 young adults between 18-39 years old who suffer from inflammation may be accepted into this clinical trial. Most importantly, applicants must meet the following criteria: They must appear healthy (assessed via health, activity, and medical history), have a BMI lower than 30, no chronic conditions that would preclude participation, and finally be able to swim for 30 minutes without taking a break."

Answered by AI

How has Oxytocin been found to be helpful for patients?

"Oxytocin nasal spray is an effective medical intervention for patients experiencing uterine contractions, hemorrhage, or childbirth."

Answered by AI

Could you please list other studies that have used Oxytocin nasal spray?

"Hadassah University Medical Organization first began studying oxytocin nasal spray in 2011. So far, there have been a total of 331 completed studies with 57 active clinical trials currently underway. The majority of these studies are being conducted out of Phoenix, Arizona."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Oxytocin for Oxidative Stress and Inflammation
2022. "Oxytocin for Oxidative Stress and Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04732247.
~13 spots leftby Apr 2025
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