NCT07140237

Brief Summary

The main aim of the present study is to investigate whether orally (lingual spray) administered oxytocin influences human top-down attention via oxytocin receptors and whether its effects are dose- and task-dependent.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

August 18, 2025

Last Update Submit

September 5, 2025

Conditions

Keywords

Oxytocin; Atosiban; Eye-tracking; Autistic traitOxytocinAtosibanEye-trackingAutistic traitattention

Outcome Measures

Primary Outcomes (2)

  • Error rates in prosaccade and antisaccade trials

    Error rates in prosaccade and antisaccade using eye- tracking technique

    Starting 45 minutes post-treatment subjects will complete the eye-tracking task with data on numbers of prosaccade and antisaccade errors being collected continuously over a period of 35 minutes.

  • Responses latencies for prosaccades and antisaccades

    response latencies for correct first saccades will be measured on each prosaccade or antisaccade trial using eye-tracking

    Starting 45 minutes post-treatment subjects will complete the eye-tracking task with data on prosaccade and antisaccade response times taken continuously during the 35 minute task

Secondary Outcomes (4)

  • Oxytocin concentration

    On the day of the experiment blood and saliva samples will be taken at time 0 (baseline) immediately prior to the first treatment, a 2nd sample will be taken at 15 minutes and a 3rd sample at 45 minutes post-treatment.

  • Pupil size

    Starting 45 minutes post-treatment continuous eye-tracking will be used to measure changes in pupil size during the whole of the 35 minute antisaccade task

  • State anxiety

    On the day of the experiment subjects will complete the questionnaire immediately prior to treatment at time 0 (baseline) and again 75 minutes post-treatment after completion of the antisaccade task

  • Correlation between prosaccade latency and antisaccade errors

    Starting 45 minutes post-treatment subjects will complete the eye-tracking task with data being collected continuously over a 35 minute period

Study Arms (5)

Oxtocin 24IU group

EXPERIMENTAL

Interventions are placebo followed after 15 minutes by the lower does (24IU) oxytocin

Drug: Oxytocin lower does (24IU)Drug: Placebo

atosiban group

EXPERIMENTAL

Interventions are placebo followed after 15 minutes by 150ug atosiban

Drug: AtosibanDrug: Placebo

placebo group

PLACEBO COMPARATOR

Interventions are placebo followed after 15 minutes by another placebo

Drug: Placebo

Oxytocin 48IU group

EXPERIMENTAL

Interventions are placebo followed after 15 minutes by the higher 48IU oxytocin does

Drug: Oxytocin higher does (48IU)Drug: Placebo

Atosiban and 24IU oxytocin group

EXPERIMENTAL

Interventions are atosiban 150ug followed after 15 minutes by the lower (24IU) does of oxytocin

Drug: Oxytocin lower does (24IU)Drug: Atosiban

Interventions

Oxytocin (24IU) will be administered as a lingual spray (6, 0.1puffs (4IU per puff) of spray on and under the tongue)

Atosiban and 24IU oxytocin groupOxtocin 24IU group

Oxytocin (48IU) will be administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on and under the tongue)

Oxytocin 48IU group

150ug atosiban administered by lingual sprays (6, 0.1ml sprays on and under the tongue)

Atosiban and 24IU oxytocin groupatosiban group

Placebo administered as a lingual spray (6, 0.1puffs (4IU per puff) of spray on and under the tongue). Placebo has the same composition of 0.9% saline and glycerol as for oxytocin and the atosiban interventions.

Oxtocin 24IU groupOxytocin 48IU groupatosiban groupplacebo group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy male subjects without past or current psychiatric or neurological disorders
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects without past or current psychiatric or neurological disorders

You may not qualify if:

  • History of or current neurological/psychiatric disorders;
  • Use of psychotropic medications (including nicotine)
  • Visual impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Life science and Technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Interventions

atosiban

Central Study Contacts

Keith M Kendrick, PhD

CONTACT

Yige Wang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized placebo-controlled double-blind between-subject design experiment including 5 treatment groups receiving oral oxytocin, atosiban, or placebo interventions prior to performing antisaccade task.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 24, 2025

Study Start

September 1, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Participant data will be shared with other qualified researchers upon request

Locations