Intranasal Oxytocin and Enhancement of Team Cohesion

NCT02302430 | Completed Phase 1

• 1 other identifier: 14-15259
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

This study attempts to identify the psychological, behavioral, physiological, and hormonal predictors and mechanisms of an individual's ability to develop cohesion in a group working together as a team; and examine if administration of the prosocial neuropeptide oxytocin enhances the development of team cohesion. Through a deeper understanding of the underlying psychobiological predictors and mechanisms of team cohesion, the prospective identification of individuals whose unique characteristics promote or inhibit the development of group cohesion will become possible.

Conditions

Unit Cohesion

Keywords

Cohesion; Oxytocin; Trust; Virtual-reality

Outcome Measures

Primary Outcomes (1)

• Change in score on computer game task

  Subjects will work together in groups of 2-4 performing a computer-based task flying a virtual plane.

  Baseline, 2 hours after drug/placebo administration

Secondary Outcomes (1)

• Change is psychophysiological output

  Time based variability analyzed for 5 minute or 20 minute events

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment group will receive either 20IU or 40IU intranasal oxytocin

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo group will receive a saline nasal spray

Other: Placebo comparator

Interventions

Oxytocin DRUG

20 International Units Intranasal Oxytocin

Also known as: Syntocinon

Treatment

Placebo comparator OTHER

Saline nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-28
• Speak English
• Ability to use a nasal spray

You may not qualify if:

• Positive urine pregnancy test
• History of psychiatric or neurologic disorder
• Use of illicit drugs in the past month
• History of moderate-severe alcohol use disorder as defined by DSM-V criteria
• Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
• Nasal obstruction, discharge, or bleeding
• Habitually drinks large volumes of water
• Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists
• Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions

Sponsors & Collaborators

• University of California, San Francisco: lead
• United States Department of Defense: collaborator
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, 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

• Josh D Woolley, MD/PhD

  University of California San Francisco, San Francisco Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: SOLO arm and ECHO arm -- Acquainted, Unacquainted

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 27, 2014
• Study Start: October 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 31, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

US (1)