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

University of Electronic Science and Technology of China

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: Oxytocin lower does (24IU); Drug: Placebo; Drug: Oxytocin higher does (48IU); Drug: Atosiban

Study type: Interventional

Funder types: Other

Identifiers

NCT07140237

UESTC-neuSCAN99

Details and patient eligibility

About

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 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.

Enrollment: 250 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 5 patient groups, including a placebo group

Oxtocin 24IU group

Experimental group

Description:

Interventions are placebo followed after 15 minutes by the lower does (24IU) oxytocin

Treatment:

Drug: Placebo

Drug: Oxytocin lower does (24IU)

atosiban group

Experimental group

Description:

Interventions are placebo followed after 15 minutes by 150ug atosiban

Treatment:

Drug: Atosiban

Drug: Placebo

placebo group

Placebo Comparator group

Description:

Interventions are placebo followed after 15 minutes by another placebo

Treatment:

Drug: Placebo

Oxytocin 48IU group

Experimental group

Description:

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

Treatment:

Drug: Oxytocin higher does (48IU)

Drug: Placebo

Atosiban and 24IU oxytocin group

Experimental group

Description:

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

Treatment:

Drug: Atosiban

Drug: Oxytocin lower does (24IU)