Healthy Adult MaleEarly Phase 1OTAtosibanNCT07140237
The Effect of Oral Oxytocin and Atosiban on Top-down Attention ( OTAtosiban )
A Early Phase 1 study testing Oxytocin lower does (24IU), Oxytocin higher does (48IU) and Atosiban in people with Healthy Adult Male, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- Oxytocin lower does (24IU), Oxytocin higher does (48IU) and Atosiban
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to 30 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects without past or current psychiatric or neurological disorders
Who cannot join
- History of or current neurological/psychiatric disorders;
- Use of psychotropic medications (including nicotine)
- Visual impairments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yige Wang, PhD contact
China1 site, 1 recruiting
- Recruiting
School of Life science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan
Yan Zhang, MSc, +86 18215678419, 532769737@qq.com
About this study
Official title: The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Top-down Attention in Humans
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.
Read the 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.
- Conditions
- Healthy Adult Male
- Being tested
- Oxytocin lower does (24IU), Oxytocin higher does (48IU), Atosiban, Placebo
- Keywords
- Oxytocin; Atosiban; Eye-tracking; Autistic trait, Oxytocin, Atosiban, Eye-tracking, Autistic trait, attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
AtosibanDrug
150ug atosiban administered by lingual sprays (6, 0.1ml sprays on and under the tongue)
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxtocin 24IU group | Experimental | Interventions are placebo followed after 15 minutes by the lower does (24IU) oxytocin Receives: Drug: Oxytocin lower does (24IU); Drug: Placebo |
| atosiban group | Experimental | Interventions are placebo followed after 15 minutes by 150ug atosiban Receives: Drug: Atosiban; Drug: Placebo |
| placebo group | Placebo comparator | Interventions are placebo followed after 15 minutes by another placebo Receives: Drug: Placebo |
| Oxytocin 48IU group | Experimental | Interventions are placebo followed after 15 minutes by the higher 48IU oxytocin does Receives: Drug: Oxytocin higher does (48IU); Drug: Placebo |
| Atosiban and 24IU oxytocin group | Experimental | Interventions are atosiban 150ug followed after 15 minutes by the lower (24IU) does of oxytocin Receives: Drug: Oxytocin lower does (24IU); Drug: Atosiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error rates in prosaccade and antisaccade trials
Error rates in prosaccade and antisaccade using eye- tracking technique
Measured: 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
response latencies for correct first saccades will be measured on each prosaccade or antisaccade trial using eye-tracking
Measured: 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 (4)
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.
Measured: 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
Pupil size will be measured during antisaccade task using eye-tracker
Measured: 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
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).
Measured: 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
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
Measured: Starting 45 minutes post-treatment subjects will complete the eye-tracking task with data being collected continuously over a 35 minute period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startSep 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled double-blind between-subject design experiment including 5 treatment groups receiving oral oxytocin, atosiban, or placebo interventions prior to performing antisaccade task.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140237
- Sponsor's protocol ID
- UESTC-neuSCAN99
- Acronym
- OTAtosiban
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be shared with other qualified researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Top-down Attention in Humans
- ClinicalTrials.gov ID
- NCT07140237
- Acronym / sponsor ID
- OTAtosiban / UESTC-neuSCAN99
- Conditions
- Healthy Adult Male
- Keywords
- Oxytocin; Atosiban; Eye-tracking; Autistic trait, Oxytocin, Atosiban, Eye-tracking, Autistic trait, attention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Randomized placebo-controlled double-blind between-subject design experiment including 5 treatment groups receiving oral oxytocin, atosiban, or placebo interventions prior to performing antisaccade task.
| Arm | Type | Receives |
|---|---|---|
| Oxtocin 24IU group | Experimental | Drug: Oxytocin lower does (24IU), Drug: PlaceboInterventions are placebo followed after 15 minutes by the lower does (24IU) oxytocin |
| atosiban group | Experimental | Drug: Atosiban, Drug: PlaceboInterventions are placebo followed after 15 minutes by 150ug atosiban |
| placebo group | Placebo comparator | Drug: PlaceboInterventions are placebo followed after 15 minutes by another placebo |
| Oxytocin 48IU group | Experimental | Drug: Oxytocin higher does (48IU), Drug: PlaceboInterventions are placebo followed after 15 minutes by the higher 48IU oxytocin does |
| Atosiban and 24IU oxytocin group | Experimental | Drug: Oxytocin lower does (24IU), Drug: AtosibanInterventions are atosiban 150ug followed after 15 minutes by the lower (24IU) does of oxytocin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (3 listed)
- History of or current neurological/psychiatric disorders;
- Use of psychotropic medications (including nicotine)
- Visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Atosiban and 24IU oxytocin group, Oxtocin 24IU group |
| 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 | Oxytocin 48IU group |
| Atosiban150ug atosiban administered by lingual sprays (6, 0.1ml sprays on and under the tongue) | Drug | Atosiban and 24IU oxytocin group, atosiban group |
| PlaceboPlacebo 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. | Drug | Oxtocin 24IU group, Oxytocin 48IU group, atosiban group, placebo group |
Primary outcome
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.
Error rates in prosaccade and antisaccade using eye- tracking technique
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
response latencies for correct first saccades will be measured on each prosaccade or antisaccade trial using eye-tracking
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. Participant data will be shared with other qualified researchers upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yige Wang, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin lower does (24IU), Oxytocin higher does (48IU) and Atosiban in people with Healthy Adult Male, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith M Kendrick, PhD (+86-28-61830811, k.kendrick.uestc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.