Intranasal Oxytocin and Enhancement of Team Cohesion

NCT ID: NCT02302430

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-05-31

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.

Conditions

Unit Cohesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

20 International Units Intranasal Oxytocin

Placebo

Placebo group will receive a saline nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: OTHER

Saline nasal spray

Interventions

Oxytocin

20 International Units Intranasal Oxytocin

Intervention Type: DRUG

Placebo comparator

Saline nasal spray

Intervention Type: OTHER

Other Intervention Names

Syntocinon

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Joshua Woolley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh D Woolley, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

14-15259

Identifier Type: -

Identifier Source: org_study_id