The Effect of Oral Oxytocin and Atosiban on Social Attention

NCT07093060 | Recruiting Early Phase 1

• 1 other identifier: 106142023111727716
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healhty

Keywords

Oxytocin; Atosiban; Eye tracking; Autistic trait

Outcome Measures

Primary Outcomes (2)

• Fixation duration

  Fixation time on different areas of interest in the different visual presentation paradigms using eye-tracking

  Fixation durations will be taken for each of the areas of interest in the four different visual paradigms starting 45 minutes post-treatment from the beginning of each paradigm until the end of each paradigm (each paradigm lasts around 10 minutes)

• Fixation counts

  Total number of fixations made by participant towards the different areas of interest in the different visual paradigms using eye-tracking

  Fixation counts will be taken for each of the areas of interest in the four different visual paradigms starting 45 minutes post-treatment, from the beginning of each paradigm until the end of each paradigm (each paradigm lasts around 10 minutes).

Secondary Outcomes (3)

• Oxytocin concentration

  Blood samples taken at time 0 (baseline), 15 minutes after first treatment, and 30 minutes after second treatment. Saliva samples taken at time 0 (baseline) and after visual paradigms (around 90 minutes post treatment).

• Pupil size

  Pupil size will be measured starting 45 min post-treatment during the whole of each of the different visual presentation paradigms (around 10 minutes for each paradigm).

• State anxiety

  Subjects will complete the questionnaire twice, once immediately prior to treatment (baseline) and a second time immediately after completion of the four visual paradigms (around 90 minutes post treatment).

Study Arms (5)

oxytocin 24IU group

EXPERIMENTAL

Interventions are placebo followed after 15 min by the lower dose (24IU) oxytocin

Drug: Oxytocin lower dose (24IU); Drug: Placebo

atosiban group

EXPERIMENTAL

Interventions are placebo followed after 15 minutes by 150ug atosiban

Drug: Atosiban; Drug: 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 dose

Drug: Oxytocin higher dose (48IU); Drug: Placebo

Atosiban and 24IU oxytocin group

EXPERIMENTAL

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

Drug: Oxytocin lower dose (24IU); Drug: Atosiban

Interventions

Oxytocin lower dose (24IU) DRUG

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

Also known as: oral oxytocin 24IU

Atosiban and 24IU oxytocin group; oxytocin 24IU group

Oxytocin higher dose (48IU) DRUG

48IU oxytocin administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on or under the tongue)

Also known as: oral oxytocin 48IU

oxytocin 48IU group

Atosiban DRUG

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

Also known as: oral atosiban

Atosiban and 24IU oxytocin group; atosiban group

Placebo DRUG

Placebo administered as a lingual spray (6, 0.1 ml sprays one and under the tongue. Placebo has the same composition of 0.9% saline and glycerol as for oxytocin and atosiban interventions

atosiban group; oxytocin 24IU group; oxytocin 48IU group; placebo group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Healthy male subjects without past or current psychiatric or neurological disorders
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

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

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Interventions

Oxytocin; atosiban

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Keith M Kendrick, PhD

CONTACT

86-28-61830811; k.kendrick.uestc@gmail.com

Yige Wang, PhD

CONTACT

86+13086688860

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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 visual attention tasks

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 30, 2025
• Study Start: June 9, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)