Current partner codePEPTIDESDE
NCT07093060·Early Phase 1·INTERVENTIONAL

The Effect of Oral Oxytocin and Atosiban on Social Attention

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 social attention and behaviors 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 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.

Interventions

Treatment arms and agents.

DRUG

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)

DRUG

Oxytocin higher dose (48IU)

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

Timeline

From registration to results.

  1. First posted

    Jul 30, 2025

  2. Study start

    Jun 9, 2025

  3. Primary completion

    Nov 30, 2025

  4. Study completion

    Nov 30, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jul 30, 2025

Outcomes

What the study measures.

Primary outcomes

Fixation duration

Time frame · 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 time on different areas of interest in the different visual presentation paradigms using eye-tracking

Fixation counts

Time frame · 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).

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

Secondary outcomes

Oxytocin concentration

Time frame · 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).

OT concentrations will be measured in blood (plasma) samples (6ml) taken from indwelling catheter in median cubital vein and saliva samples (1-2 ml) taken using passive drool. Oxytocin concentrations will be measured using appropriate assays.

Pupil size

Time frame · 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).

Pupil size will be measured while subjects view different areas of interest in different visual presentation paradigms using an eye-tracker

State anxiety

Time frame · 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).

State anxiety will be measured using a questionnaire (40 self-report question - State-Trait Anxiety Inventory, with total scores ranging from 20 to 80, where higher scores indicate greater anxiety).

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.

Related PeptideStat pages

Put the record in context.

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