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

The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Top-down Attention in Humans

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07140237
Acronym
OTAtosiban
Enrollment
250
Registered
2025-08-24
Start date
2025-09-30
Completion date
2025-12-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Male

Keywords

Oxytocin; Atosiban; Eye-tracking; Autistic trait, Oxytocin, Atosiban, Eye-tracking, Autistic trait, attention

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.

Interventions

DRUGOxytocin 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)

DRUGOxytocin higher does (48IU)

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

DRUGAtosiban

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

DRUGPlacebo

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.

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Error rates in prosaccade and antisaccade trialsStarting 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.Error rates in prosaccade and antisaccade using eye- tracking technique
Responses latencies for prosaccades and antisaccadesStarting 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 taskresponse latencies for correct first saccades will be measured on each prosaccade or antisaccade trial using eye-tracking

Secondary

MeasureTime frameDescription
Pupil sizeStarting 45 minutes post-treatment continuous eye-tracking will be used to measure changes in pupil size during the whole of the 35 minute antisaccade taskPupil size will be measured during antisaccade task using eye-tracker
Oxytocin concentrationOn 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.OT concentrations will be measured in blood (plasma) samples (6ml) taken from indwelling catheter in median cubital vein and saliva samples (1-2ml) taken using passive drool. OT concentrations will be measured using appropriate essays.
State anxietyOn 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 taskState anxiety will be measured using a questionnaire (40 self-report question-state-trait-anxiety inventory, with total scores ranging from 20-80, where higher scores indicate greater anxiety).
Correlation between prosaccade latency and antisaccade errorsStarting 45 minutes post-treatment subjects will complete the eye-tracking task with data being collected continuously over a 35 minute periodThe correlation between two of the primary outcome measures (prosaccade latencies and antisaccade errors) taken during trials will be analyzed using the Spearman correlation test for each treatment group. Differences between correlations in the groups will be assessed using Fisher's z tests

Countries

China

Contacts

Primary ContactKeith M Kendrick, PhD
k.kendrick.uestc@gmail.com+86-28-61830811
Backup ContactYige Wang, PhD
+86-13086688860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026