The Effect of Oral Oxytocin and Atosiban on Social Attention

NCT ID: NCT07093060

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2025-11-30

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.

Detailed Description

In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate whether oral (lingual spray) oxytocin influences human social attention and behaviors via the oxytocin receptor and whether its effects are dose- and task-dependent. Participants complete questionnaires in Chinese versions before treatment administration, including Trait Anxiety Inventory, State Anxiety Inventory, Liebowitz Social Anxiety Scale, Beck Depression Inventory, Autism Spectrum Quotient. Then the first blood (6 ml 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. Participants then remain in the lab for 30 minutes (mobile phone use and conversation with experimenters prohibited during this period). Behavioral experiments commence after the third blood collection. Behavioral experiment consists of four visual attention paradigms including a dynamic task simultaneously contrasting social stimuli (individuals dancing) with geometric patterns; social directed attention using a gaze following paradigm; face emotion processing, and empathy for individuals depicted in natural scenes exhibiting strong positive or negative emotions. During these phases, participants' fixation time, fixation counts and pupil size on specified areas of interest during each visual attention paradigm will be measured using eye tracking equipment. Immediately after completion of the paradigm, participants will complete the state anxiety questionnaire again to assess treatment/paradigm effects on anxiety.

MANOVA tests followed by appropriate post-hoc analyses will be performed on eye-tracking and other data to assess treatment effects. Correlation analysis will be used to assess associations between trait autism scores and outcome measures in the different groups.

Investigators hypothesize that oral oxytocin treatment will dose-dependently facilitate enhanced interest in social stimuli or features in the different visual attention paradigms and dose-dependently increase oxytocin concentrations. Investigators additionally hypothesize that the oxytocin receptor antagonist, atosiban, will reduce interest in social stimuli or features and will prevent facilitatory effects of oxytocin administration but not influence oxytocin concentrations. Investigators hypothesize that oxytocin treatment will increase pupil diameter while viewing some of the social stimuli. Investigators hypothesize that there will be no treatment-dependent effects on state anxiety. Investigators hypothesize that oxytocin effects on enhancing social attention will be greater in individuals with higher scores on trait autism.

Conditions

Healhty

Study Design

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

Study Groups

oxytocin 24IU group

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

Group Type: EXPERIMENTAL

Oxytocin lower dose (24IU)

Intervention Type: DRUG

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

Placebo

Intervention Type: 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

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

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

oxytocin 48IU group

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

Group Type: EXPERIMENTAL

Oxytocin higher dose (48IU)

Intervention Type: DRUG

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

Placebo

Intervention Type: 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 and 24IU oxytocin group

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

Group Type: EXPERIMENTAL

Oxytocin lower dose (24IU)

Intervention Type: DRUG

Oxytocin (24IU) will be administered as a lingual spray (6, 0.1 puffs (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 dose (24IU)

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

Intervention Type: DRUG

Oxytocin higher dose (48IU)

48IU oxytocin administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on or 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, 0.1 ml sprays one and under the tongue. Placebo has the same composition of 0.9% saline and glycerol as for oxytocin and atosiban interventions

Intervention Type: DRUG

Other Intervention Names

oral oxytocin 24IU; oral oxytocin 48IU; oral atosiban

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

106142023111727716

Identifier Type: -

Identifier Source: org_study_id