Health TrialsbyHealthPanel

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

ConditionHealthy Adult Male
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 top-down attention 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 does (24IU)

    Drug

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

  • Oxytocin higher does (48IU)

    Drug

    Oxytocin (48IU) will be administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on and 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, 0.1puffs (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.

Treatment groups

250 Participants
are divided into 5 treatment groups
Group A: Oxtocin 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

Error rates in prosaccade and antisaccade trials

Error rates in prosaccade and antisaccade using eye- tracking technique

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.
2

Responses latencies for prosaccades and antisaccades

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

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 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 (1-2ml) taken using passive drool. OT concentrations will be measured using appropriate essays.

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.
2

Pupil size

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

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
3

State anxiety

State anxiety will be measured using a questionnaire (40 self-report question-state-trait-anxiety inventory, with total scores ranging from 20-80, where higher scores indicate greater 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
4

Correlation between prosaccade latency and antisaccade errors

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

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

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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