Intranasal Oxytocin and Enhancement of Team Cohesion

Phase 1

Completed

• Conditions: Unit Cohesion
• Interventions: Drug: Oxytocin; Other: Placebo comparator

• Registration Number: NCT02302430
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

The investigators will study up to one thousand subjects who will be randomized into same-gendered teams of three or volunteer as acquainted groups of three . Teams will be randomized to receive oxytocin or placebo. The investigators will first measure baseline personality traits including prosocial orientation. Cohesion will then be measured using a cooperative, virtual unmanned aerial vehicle (UAV) flying mission. All online behavior will be recorded within the task and all offline, real world, behavior will be video recorded throughout the study by digital cameras for later behavioral coding. To measure biobehavioral synchrony, autonomic physiology will be recorded and saliva samples will be taken throughout behavioral testing.

Study Timeline

• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Study Start: 2015-10
• Primary Completion: 2018-05
• Study Completion: 2019-05-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Oxytocin	Treatment group will receive either 20IU or 40IU intranasal oxytocin
Placebo	Placebo comparator	Placebo group will receive a saline nasal spray

Primary Outcome Measures

Name	Time	Method
Change in score on computer game task	Baseline, 2 hours after drug/placebo administration	Subjects will work together in groups of 2-4 performing a computer-based task flying a virtual plane.

Secondary Outcome Measures

Name	Time	Method
Change is psychophysiological output	Time based variability analyzed for 5 minute or 20 minute events	Cardiac measures (HRV, Impedance) collected during computer based and group activities

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States