The Effect of Oral Oxytocin and Atosiban on Top-down Attention ( OTAtosiban )

NCT ID: NCT07140237

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-12-30

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.

Detailed Description

In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate whether oral (lingual spray) oxytocin influences human top-down attention via the oxytocin receptor and whether its effects are dose- and task-dependent. Subjects complete questionnaires in Chinese versions before treatment administration, including Behavioral Activation System scale, Behavioral Inhibition System scale,Trait Anxiety Inventory, State Anxiety Inventory, Liebowitz Social Anxiety Scale, Beck Depression Inventory, Autism Spectrum Quotient. Then the first blood (6ml via indwelling medial cubital vein catheter) and saliva (1-2 ml, passive drool) samples are collected, followed by the first self-administered medication (three sublingual and three supragingival administrations, alternating separated by 30 seconds). After a 15-minute interval, the second medication is administered, with a second blood sample collected immediately afterwards. Subjects then remain in the lab for 30 minutes (mobile phone use and conversation with experimenters are prohibited during this period). Behavioral experiment (antisaccade) commences after the third blood collection. During these phases, subjects' latency of correct trials, error rate and pupil size in response to stimuli will be measured using eye tracking equipment. Immediately after completion of the paradigm subjects will complete the state anxiety questionnaire again to assess treatment/paradigm effects on anxiety.

A Mixed linear model, followed by appropriate post-hoc analyses will be used on eye-tracking and other data to assess treatment effects. Correlation analysis will be used to assess associations between latency of correct trials in prosaccade and error rate in antisaccade in the different groups. Investigators make the following hypotheses according to our previous studies: first, oral oxytocin treatment will dose-dependently decrease top-down attention to social but also non-social stimuli; secondly, oxytocin concentrations will be dependent on the dose of oral administration and will not be influenced by oral administration of the oxytocin receptor antagonist (atosiban) administration; thirdly, atosiban is anticipated to have the opposite effect of oral oxytocin and may not interfere with top-down attention; fourthly, oxytocin treatment will increase pupil diameter while viewing social stimuli; fifthly, there will be treatment- dependent effects on post-task state anxiety scores; lastly, antisaccade performance in each group might be influenced by subjects' scores on autistic traits.

Conditions

Healthy Adult Male

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Oxtocin 24IU group

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

Group Type: EXPERIMENTAL

Oxytocin lower does (24IU)

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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.

atosiban group

Interventions are placebo followed after 15 minutes by 150ug atosiban

Group Type: EXPERIMENTAL

Atosiban

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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.

placebo group

Interventions are placebo followed after 15 minutes by another placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Oxytocin 48IU group

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

Group Type: EXPERIMENTAL

Oxytocin higher does (48IU)

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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.

Atosiban and 24IU oxytocin group

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

Group Type: EXPERIMENTAL

Oxytocin lower does (24IU)

Intervention Type: DRUG

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

Atosiban

Intervention Type: DRUG

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

Interventions

Oxytocin lower does (24IU)

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

Intervention Type: DRUG

Oxytocin higher does (48IU)

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

Intervention Type: DRUG

Atosiban

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

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Keith Kendrick

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Keith M Kendrick, PhD

Role: CONTACT

k.kendrick.uestc@gmail.com

+86-28-61830811

Yige Wang, PhD

Role: CONTACT

+86-13086688860

Facility Contacts

Yan Zhang, MSc

Role: primary

532769737@qq.com

+86 18215678419

Other Identifiers

UESTC-neuSCAN99

Identifier Type: -

Identifier Source: org_study_id