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Recruiting NCT07140237

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

Early Phase I Interventional Healthy Adult Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxytocin lower does (24IU), Oxytocin higher does (48IU), Atosiban, Placebo.
Who it may be relevant to
Registry conditions: Healthy Adult Male. Basic parameters: 18 years — 35 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • 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.]
  • 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]
Secondary outcome measures (4)
  • 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.]
  • 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]
  • 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

China · 1 center
  • School of Life science and Technology, University of Electronic Science and Technology of — Chengdu

Identifiers

NCT: NCT07140237 · UESTC-neuSCAN99

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗