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Peptide Hormone

Oxytocin nasal spray for Cold Exposure

Phase 2
Waitlist Available
Led By Thaddeus Light, Ph.D.
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 within 3 hours post-treatment
Awards & highlights

Study Summary

This trial will evaluate the effects of intranasal oxytocin on cold water immersion performance and physiological recovery from repeated immersion bouts in NSW operators.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 hours post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 hours post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive performance assessment score change (code substitution)
Cognitive performance assessment score change (reaction time)
Oculometric assessment score change (blink duration)
+2 more
Secondary outcome measures
Reduced rating of perceived exertion (RPE) during physical assessment post-cold water exposure
Other outcome measures
Difference in grip strength in cold water
Difference in manual dexterity (underwater knot untying) in cold water
Difference in manual dexterity (underwater peg board assessment) in cold water

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
Single dose of intranasal oxytocin (48 IU) prior to testing protocol.
Group II: Placebo Nasal SprayPlacebo Group1 Intervention
Single dose of 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?

Florida Institute for Human and Machine CognitionLead Sponsor
4 Previous Clinical Trials
271 Total Patients Enrolled
University of FloridaOTHER
1,339 Previous Clinical Trials
717,595 Total Patients Enrolled
Office of Naval Research (ONR)FED
14 Previous Clinical Trials
705 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 research project open to individuals elderly than 85?

"Within the age bracket of 18 to 39, this trial is open for enrolment."

Answered by AI

What benefits have been observed with Oxytocin nasal spray?

"Oxytocin nasal spray is a potent tool for treating hemorrhage, as well as other scenarios such as childbirth and uterine contractions."

Answered by AI

Has the Federal Drug Administration authorized Oxytocin nasal spray for use?

"Our team at Power believes that oxytocin nasal spray is moderately safe, awarding it a score of 2. This rating reflects the fact that while there are some safety data points available, none have been collected regarding efficacy."

Answered by AI

What is the total cohort size of this experiment?

"At this time, no further participants are being recruited for the trial. The initial posting was on July 1st 2021 and it has been amended as recently as February 1st 2021. If you are looking to join other medical studies, there are currently 3 trials involving cold exposure and 53 inquiries into Oxytocin nasal spray that have open enrollment."

Answered by AI

To what extent am I qualified to be a participant in this experiment?

"The requirements for this experiment include 24 participants aged between 18 and 39 who are adept at swimming. Moreover, they should have some familiarity with cold exposure conditions."

Answered by AI

Is enrollment for this experiment currently available?

"According to the information provided on clinicaltrials.gov, this particular trial is not presently enrolling participants; it was initially posted and last updated in 2021. Nevertheless, there are 56 other medically-related studies that are currently recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Oxytocin on Cold Water Task Performance and Recovery
2022. "Oxytocin on Cold Water Task Performance and Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04738838.
~6 spots leftby Apr 2025
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