Faces: Choices Study

NCT02409862 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: IRB201600718 -A39-2013 SubStudy
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The neuropeptide oxytocin (OXT), originally known for its role in inducing uterine contractions has been shown to be involved in many of the social capacities that seem to change with age, such as emotion detection and identification, enhanced social memory, empathy, and trust. Thus, age-related changes in the OXT system may underlie differences between young and older adults in socioemotional functioning. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging. The aim of this research is to examine the behavioral and neural effects of OXT on decisions of trust in social interactions, perceptions of facial trustworthiness, the ability to read faces, and levels of empathy with other people in samples of young and older adults.

Conditions

Socioemotional Aging

Keywords

oxytocin; socioemotional functioning; aging

Outcome Measures

Primary Outcomes (1)

• The change in choices task between baseline and at week 2

  Interactive computer task that determines willingness to give money to a fellow player.

  Change between baseline and at week 2

Secondary Outcomes (6)

• The change in General Trust Measure Questionnaire between baseline and at week 2

  Change between baseline and at week 2

• The change in Empathy Quotient Questionnaire between baseline and at week 2

  Change between baseline and at week 2

• The change in Trait Meta-Mood Scale Questionnaire between baseline and at week 2

  Change between baseline and at week 2

• The change in Inclusion of Community in the Self Scale Questionnaire between baseline and at week 2

  Change between baseline and at week 2

• Gift basket task

  Week 2

Study Arms (2)

Oxytocin Spray

EXPERIMENTAL

This group will receive the single dose of 24 IU oxytocin, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.

Drug: Oxytocin Spray

Placebo spray

PLACEBO COMPARATOR

This group will receive the single dose of 24 IU saline, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.

Drug: Placebo Spray

Interventions

Oxytocin Spray DRUG

This group will receive the single dose of 24 IU oxytocin, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.

Also known as: synthetic oxytocin

Oxytocin Spray

Placebo Spray DRUG

This group will receive the single dose of 24 IU placebo, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.

Also known as: saline spray

Placebo spray

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-33 (for the younger adults) and 60-85 (for the older adults)
• Male
• Caucasian
• English fluency

You may not qualify if:

• Severe claustrophobia
• Currently on vasoconstrictors, pseudoephedrine or antidiuretic medication
• Surgery on the brain or any prior serious brain damage or disease
• Dementia or severe cognitive disorders
• History of hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone, psychogenic polydipsia, or motion disorder

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611-2250, United States

Location

Study Officials

• Natalie C Ebner, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 7, 2015
• Study Start: January 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

US (1)