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Intranasal Oxytocin and Enhancement of Team Cohesion
Plain-language guide to NCT02302430: phase 1 randomized trial of Oxytocin, 486 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02302430
- Phase
- phase 1
- Status
- completed
- Start
- 2015-10
- Completion (planned or actual)
- 2018-05
- Participants
- 486 (actual)
- Design
- randomized, triple-blind, other
- Conditions studied
- Unit Cohesion
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Oxytocin.
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.
It had two arms (groups): Treatment (experimental) and Placebo (placebo comparator).
Placebo group will receive a saline nasal spray.
The registry classes the interventions as drug and other.
More on the Plan
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.
Who Took Part
Enrollment: 486 actual participants took part.
It was open to people of any sex aged from 18 years up to 28 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Ability to use a nasal spray.
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: positive urine pregnancy test; history of psychiatric or neurologic disorder; use of illicit drugs in the past month.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Oxytocin group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2015-10 with completion listed for 2018-05.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Researchers chose this as the main measure: Change in score on computer game task (time frame: Baseline, 2 hours after drug/placebo administration).
It also tracked 1 secondary outcome, for example Change is psychophysiological output.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Oxytocin in 486 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.