Oxytocin on Cold Water Task Performance and Recovery

NCT04738838 | Completed Phase 2 FDA Drug

• 1 other identifier: IRB-2020-0002
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cold Exposure

Outcome Measures

Primary Outcomes (7)

• Cognitive performance assessment score change (code substitution)

  Changes in code substitution scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in milliseconds for response time.

  Within 3 hours post-treatment

• Cognitive performance assessment score change (code substitution)

  Changes in code substitution scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in number of correct or incorrect responses.

  Within 3 hours post-treatment

• Cognitive performance assessment score change (reaction time)

  Changes in choice reaction time scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in milliseconds for response time.

  Within 3 hours post-treatment

• Cognitive performance assessment score change (reaction time)

  Changes in choice reaction time scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in number of correct or incorrect responses.

  Within 3 hours post-treatment

• Oculometric assessment score change (saccades)

  Altered ocular response as measured by the I-Portal Portable Assessment System (i-PAS). Saccades will be monitored and counted throughout the duration of the assessment.

  Within 3 hours post-treatment

• Oculometric assessment score change (blink rate)

  Altered ocular response as measured by the I-Portal Portable Assessment System (i-PAS). Number of blinks will be counted through the course of the assessment.

  Within 3 hours post-treatment

• Oculometric assessment score change (blink duration)

  Altered ocular response in blink duration as measured by the I-Portal Portable Assessment System (i-PAS). Blink duration will be measured in milliseconds.

  Within 3 hours post-treatment

Secondary Outcomes (1)

• Reduced rating of perceived exertion (RPE) during physical assessment post-cold water exposure

  Within 3 hours post-treatment

Other Outcomes (3)

• Difference in grip strength in cold water

  Within 3 hours post-treatment

• Difference in manual dexterity (underwater knot untying) in cold water

  Within 3 hours post-treatment

• Difference in manual dexterity (underwater peg board assessment) in cold water

  Within 3 hours post-treatment

Study Arms (2)

Oxytocin Nasal Spray

EXPERIMENTAL

Single dose of intranasal oxytocin (48 IU) prior to testing protocol.

Drug: Oxytocin nasal spray

Placebo Nasal Spray

PLACEBO COMPARATOR

Single dose of intranasal treatment with placebo (identical to oxytocin nose spray minus the oxytocin)

Drug: Placebo nasal spray

Interventions

Oxytocin nasal spray DRUG

Intranasal treatment with oxytocin via nasal spray (48 IU per dose)

Also known as: Oxytocin

Oxytocin Nasal Spray

Placebo nasal spray DRUG

Intranasal treatment with placebo via nasal spray

Also known as: Placebo

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recreationally skilled swimmers

You may not qualify if:

• Smoking/vaping, a history of psychiatric disorders, safety requirements related to the oxytocin administration \[hypersensitivity to oxytocin or vasopressin, history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia, on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication, or anti-inflammatory drugs, or muscle relaxants, low sodium and high osmolality levels, excessive smoking, excessive drinking, and significant nasal pathology.

Sponsors & Collaborators

• Florida Institute for Human and Machine Cognition: lead
• Office of Naval Research (ONR): collaborator
• University of Florida: collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

Florida Institute for Human and Machine Cognition

Pensacola, Florida, 32502, United States

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marcas Bamman, Ph.D.

  Florida Institute for Human and Machine Cognition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All will remain blinded until completion of human subjects data collection except the research pharmacist providing intranasal oxytocin or placebo.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized crossover design

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: February 4, 2021
• Study Start: May 20, 2022
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)