HealhtyEarly Phase 1OTAtosibanNCT07093060
The Effect of Oral Oxytocin and Atosiban on Social Attention
A Early Phase 1 study testing Oxytocin lower dose (24IU), Oxytocin higher dose (48IU) and Atosiban in people with Healhty, 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 social attention and behaviors 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
- Healhty
- What is being tested?
- Oxytocin lower dose (24IU), Oxytocin higher dose (48IU) and Atosiban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2025to 30 Nov 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, 611731
Yan Zhang, MSc, +86 18215678419, 532769737@qq.com
About this study
Official title: The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Social Attention in Humans
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.
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 social attention and behaviors via the oxytocin receptor and whether its effects are dose- and task-dependent. Participants complete questionnaires in Chinese versions before treatment administration, including Trait Anxiety Inventory, State Anxiety Inventory, Liebowitz Social Anxiety Scale, Beck Depression Inventory, Autism Spectrum Quotient. Then the first blood (6 ml 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. Participants then remain in the lab for 30 minutes (mobile phone use and conversation with experimenters prohibited during this period). Behavioral experiments commence after the third blood collection. Behavioral experiment consists of four visual attention paradigms including a dynamic task simultaneously contrasting social stimuli (individuals dancing) with geometric patterns; social directed attention using a gaze following paradigm; face emotion processing, and empathy for individuals depicted in natural scenes exhibiting strong positive or negative emotions. During these phases, participants' fixation time, fixation counts and pupil size on specified areas of interest during each visual attention paradigm will be measured using eye tracking equipment. Immediately after completion of the paradigm, participants will complete the state anxiety questionnaire again to assess treatment/paradigm effects on anxiety.
MANOVA tests followed by appropriate post-hoc analyses will be performed on eye-tracking and other data to assess treatment effects. Correlation analysis will be used to assess associations between trait autism scores and outcome measures in the different groups.
Investigators hypothesize that oral oxytocin treatment will dose-dependently facilitate enhanced interest in social stimuli or features in the different visual attention paradigms and dose-dependently increase oxytocin concentrations. Investigators additionally hypothesize that the oxytocin receptor antagonist, atosiban, will reduce interest in social stimuli or features and will prevent facilitatory effects of oxytocin administration but not influence oxytocin concentrations. Investigators hypothesize that oxytocin treatment will increase pupil diameter while viewing some of the social stimuli. Investigators hypothesize that there will be no treatment-dependent effects on state anxiety. Investigators hypothesize that oxytocin effects on enhancing social attention will be greater in individuals with higher scores on trait autism.
- Conditions
- Healhty
- Being tested
- Oxytocin lower dose (24IU), Oxytocin higher dose (48IU), Atosiban, Placebo
- Keywords
- Oxytocin, Atosiban, Eye tracking, Autistic trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin lower dose (24IU)Drug
Also called oral oxytocin 24IU
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
Also called oral oxytocin 48IU
48IU oxytocin administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on or under the tongue)
AtosibanDrug
Also called oral atosiban
150ug atosiban administered by lingual sprays (6, 0.1ml sprays on and under the tongue)
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| oxytocin 24IU group | Experimental | Interventions are placebo followed after 15 min by the lower dose (24IU) oxytocin Receives: Drug: Oxytocin lower dose (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 dose Receives: Drug: Oxytocin higher dose (48IU); Drug: Placebo |
| Atosiban and 24IU oxytocin group | Experimental | Interventions are atosiban 150ug followed after 15 minutes by the lower (24IU) dose of oxytocin Receives: Drug: Oxytocin lower dose (24IU); Drug: Atosiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixation duration
Fixation time on different areas of interest in the different visual presentation paradigms using eye-tracking
Measured: 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)
Fixation counts
Total number of fixations made by participant towards the different areas of interest in the different visual paradigms using eye-tracking
Measured: 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 (3)
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.
Measured: 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).
Pupil size
Pupil size will be measured while subjects view different areas of interest in different visual presentation paradigms using an eye-tracker
Measured: 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).
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start9 Jun 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies 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
- 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 visual attention tasks
- 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
- NCT07093060
- Sponsor's protocol ID
- 106142023111727716
- Acronym
- OTAtosiban
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 30 Jul 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 30 Jul 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 Social Attention in Humans
- ClinicalTrials.gov ID
- NCT07093060
- Acronym / sponsor ID
- OTAtosiban / 106142023111727716
- Conditions
- Healhty
- Keywords
- Oxytocin, Atosiban, Eye tracking, Autistic trait
- 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
- 9 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Jul 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 social attention and behaviors 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 social attention and behaviors via the oxytocin receptor and whether its effects are dose- and task-dependent. Participants complete questionnaires in Chinese versions before treatment administration, including Trait Anxiety Inventory, State Anxiety Inventory, Liebowitz Social Anxiety Scale, Beck Depression Inventory, Autism Spectrum Quotient. Then the first blood (6 ml 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. Participants then remain in the lab for 30 minutes (mobile phone use and conversation with experimenters prohibited during this period). Behavioral experiments commence after the third blood collection. Behavioral experiment consists of four visual attention paradigms including a dynamic task simultaneously contrasting social stimuli (individuals dancing) with geometric patterns; social directed attention using a gaze following paradigm; face emotion processing, and empathy for individuals depicted in natural scenes exhibiting strong positive or negative emotions. During these phases, participants' fixation time, fixation counts and pupil size on specified areas of interest during each visual attention paradigm will be measured using eye tracking equipment. Immediately after completion of the paradigm, participants will complete the state anxiety questionnaire again to assess treatment/paradigm effects on anxiety.
MANOVA tests followed by appropriate post-hoc analyses will be performed on eye-tracking and other data to assess treatment effects. Correlation analysis will be used to assess associations between trait autism scores and outcome measures in the different groups.
Investigators hypothesize that oral oxytocin treatment will dose-dependently facilitate enhanced interest in social stimuli or features in the different visual attention paradigms and dose-dependently increase oxytocin concentrations. Investigators additionally hypothesize that the oxytocin receptor antagonist, atosiban, will reduce interest in social stimuli or features and will prevent facilitatory effects of oxytocin administration but not influence oxytocin concentrations. Investigators hypothesize that oxytocin treatment will increase pupil diameter while viewing some of the social stimuli. Investigators hypothesize that there will be no treatment-dependent effects on state anxiety. Investigators hypothesize that oxytocin effects on enhancing social attention will be greater in individuals with higher scores on trait autism.
Study design
- Primary purpose
- Basic science
- Allocation
- 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 visual attention tasks
| Arm | Type | Receives |
|---|---|---|
| oxytocin 24IU group | Experimental | Drug: Oxytocin lower dose (24IU), Drug: PlaceboInterventions are placebo followed after 15 min by the lower dose (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 dose (48IU), Drug: PlaceboInterventions are placebo followed after 15 minutes by the higher 48IU oxytocin dose |
| Atosiban and 24IU oxytocin group | Experimental | Drug: Oxytocin lower dose (24IU), Drug: AtosibanInterventions are atosiban 150ug followed after 15 minutes by the lower (24IU) dose 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 dose (24IU)Also: oral oxytocin 24IUOxytocin (24IU) will be administered as a lingual spray (6, 0.1 puffs (4IU per puff) of spray on and under the tongue) | Drug | Atosiban and 24IU oxytocin group, oxytocin 24IU group |
| Oxytocin higher dose (48IU)Also: oral oxytocin 48IU48IU oxytocin administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on or under the tongue) | Drug | oxytocin 48IU group |
| AtosibanAlso: oral 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, 0.1 ml sprays one and under the tongue. Placebo has the same composition of 0.9% saline and glycerol as for oxytocin and atosiban interventions | Drug | atosiban group, oxytocin 24IU group, oxytocin 48IU group, placebo group |
Primary outcome
Fixation duration
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)
Fixation time on different areas of interest in the different visual presentation paradigms using eye-tracking
Fixation counts
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).
Total number of fixations made by participant towards the different areas of interest in the different visual paradigms using eye-tracking
3 secondary outcomes
Oxytocin concentration
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).
Pupil size
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).
State 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).
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 30 Jul 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 dose (24IU), Oxytocin higher dose (48IU) and Atosiban in people with Healhty, 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 30 Jul 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?
Fixation duration (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)). 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 30 Jul 2025.