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The Effect of Oral Oxytocin and Atosiban on Social Attention

ConditionHealhty
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-35
SponsorUniversity of Electronic Science and Technology of China

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male subjects without past or current psychiatric or neurological disorders

Disqualifiers

History of or current neurological/psychiatric disorders;

Use of psychotropic medications (including nicotine)

Visual impairments

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxytocin lower dose (24IU)

    Drug

    Oxytocin (24IU) will be administered as a lingual spray (6, 0.1 puffs (4IU per puff) of spray on and under the tongue)

  • Oxytocin higher dose (48IU)

    Drug

    48IU oxytocin administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on or under the tongue)

  • Atosiban

    Drug

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

  • Placebo

    Drug

    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

Treatment groups

250 Participants
are divided into 5 treatment groups
Group A: oxytocin 24IU groupExperimental treatment 2 interventions
Group B: atosiban groupExperimental treatment 2 interventions
Group C: placebo groupPlacebo comparator 1 intervention
Group D: oxytocin 48IU groupExperimental treatment 2 interventions
Group E: Atosiban and 24IU oxytocin groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Fixation duration

Fixation time on different areas of interest in the different visual presentation paradigms using eye-tracking

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)
2

Fixation counts

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

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).

Secondary outcomes

1

Oxytocin concentration

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.

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).
2

Pupil size

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

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).
3

State anxiety

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).

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Electronic Science and Technology of China

Lead sponsor

Source ClinicalTrials.gov
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