NCT05245708

Brief Summary

The main aim of the study is to investigate whether intranasal oxytocin has effects on reinforcement learning under dynamic environment and interoceptive processing based on behavioral and electroencephalogram (EEG) responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2021

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

April 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

February 7, 2022

Last Update Submit

January 17, 2024

Conditions

Healthy

Keywords

oxytocinlearninginteroception

Outcome Measures

Primary Outcomes (2)

  • Behavioral index in the learning task: chioce accuracy

    The accuracy of subjects choosing the better option.

    45-65 minutes after treatment administration

  • Behavioral index in the heartbeat counting task: interoceptive accuracy

    Individuals' ability to perceive internal cardiac signals

    65-75 minutes after treatment administration

Secondary Outcomes (2)

  • ERP components in the learning task: ERN, FRN, P300, N2pc

    45-65 minutes after treatment administration

  • ERP components in the heartbeat counting task: heartbeat-evoked potential (HEP)

    65-75 minutes after treatment administration

Study Arms (2)

oxytocin

EXPERIMENTAL

a single dose of 24 international units (IU) of OT will be administered with 3 puffs of treatment to each nostril.

Drug: Intranasal oxytocin

placebo

EXPERIMENTAL

a single dose of 24 international units (IU) of placebo will be administered with 3 puffs of treatment to each nostril.

Drug: intranasal placebo

Interventions

Intranasal oxytocinDRUG

Each subject will be assigned to intranasal administration of oxytocin (24 IU).

oxytocin
intranasal placeboDRUG

Each subject will be assigned to intranasal placebo.

placebo

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects without any past or present psychiatric or neurological disorders.

You may not qualify if:

  • History of brain injury medical or mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China (UESTC)

Chengdu, Sichuan, 611731, China

Location

Study Officials

  • Yao Shuxia, Dr

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 18, 2022

Study Start

April 15, 2021

Primary Completion

September 20, 2021

Study Completion

December 15, 2021

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

CN(1)