Current partner codePEPTIDESDE
NCT07140237·Early Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Early Phase 1

Enrollment

250

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

DRUG

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)

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)

DRUG

Atosiban

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

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.

Timeline

From registration to results.

  1. First posted

    Aug 24, 2025

  2. Study start

    Sep 2025

  3. Primary completion

    Dec 30, 2025

  4. Study completion

    Dec 30, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Sep 8, 2025

Outcomes

What the study measures.

Primary outcomes

Error rates in prosaccade and antisaccade trials

Time frame · 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.

Error rates in prosaccade and antisaccade using eye- tracking technique

Responses latencies for prosaccades and antisaccades

Time frame · 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

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

Secondary outcomes

Oxytocin concentration

Time frame · 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.

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.

Pupil size

Time frame · 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

Pupil size will be measured during antisaccade task using eye-tracker

State anxiety

Time frame · 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

State 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 errors

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

The 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
35 Years
Sex
MALE
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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

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

Chengdu, Sichuan, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Atosiban.

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