NCT03228901

Brief Summary

In this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

July 21, 2017

Last Update Submit

July 25, 2017

Conditions

Social Interaction

Keywords

OxytocinAffiliation

Outcome Measures

Primary Outcomes (1)

  • Non-verbal communication

    Based on coding the video-recorded interaction between two strangers, using a coding scheme by Gonzaga et al. (for affiliative and sexual cues)

    Measured in the interaction which commenced 45mins after drug administration

Secondary Outcomes (1)

  • Ratings of the person participants interacted with

    Measured following the interaction (which commenced 45 mins after drug administration)

Study Arms (2)

Oxytocin

EXPERIMENTAL

24IU Syntocinon, delivered in a single nose via a nasal spray

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Matched nasal spray

Drug: Placebos

Interventions

OxytocinDRUG

Administration of the hormone oxytocin

Also known as: Syntocinon
Oxytocin
PlacebosDRUG
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy

You may not qualify if:

  • pregnant;
  • history of epilepsy, severe depression, severe anxiety, or psychosis;
  • smoking more than 15 cigarettes a day;
  • addicted to illegal substances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New South Wales

Sydney, New South Wales, 2052, Australia

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 25, 2017

Study Start

January 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)