Social InteractionPhase 2NCT03228901
Oxytocin and Non-verbal Communication
A Phase 2 study testing Oxytocin in people with Social Interaction, run by Yale-NUS College at 1 site in Australia.
Trial summary
In this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Social Interaction
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2007to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy
Who cannot join
- pregnant;
- history of epilepsy, severe depression, severe anxiety, or psychosis;
- smoking more than 15 cigarettes a day;
- addicted to illegal substances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effects of Oxytocin on Non-verbal Communication
In this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.
Read the detailed description
Using Liu et al.'s (2012) dataset, the investigators seek to observe whether the administration of oxytocin modifies non-verbal communication with a stranger.
This dataset involves a conversation between two strangers that took place 45 minutes after drug administration. While Liu et al. coded the video for markers of interpersonal distance (physical distance, eye contact, conversational intimacy), the investigators seek to analyse oxytocin's effects on non-verbal communication of affiliative and sexual cues (e.g., smiles, lip puckers). Based on findings that oxytocin's effects depend on context, the investigators will explore these relationships as a function of the conversational context (where participants converse with each other using low-, medium-, and high-intimacy topics, or in an unstructured conversation).
- Conditions
- Social Interaction
- Being tested
- Oxytocin, Placebos
- Keywords
- Oxytocin, Affiliation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
Administration of the hormone oxytocin
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 24IU Syntocinon, delivered in a single nose via a nasal spray Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Matched nasal spray Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-verbal communication
Based on coding the video-recorded interaction between two strangers, using a coding scheme by Gonzaga et al. (for affiliative and sexual cues)
Measured: Measured in the interaction which commenced 45mins after drug administration
Secondary outcomes (1)
Ratings of the person participants interacted with
Positivity or sexual attraction towards the other participant in the conversation (as measured using visual analogue scales based on person perception studies)
Measured: Measured following the interaction (which commenced 45 mins after drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startJan 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social InteractionStudies 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
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Liu, Yale-NUS College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228901
- Sponsor's protocol ID
- IG15-B052
- Status last verified
- Jul 2017
- First submitted
- 21 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Oxytocin on Non-verbal Communication
- ClinicalTrials.gov ID
- NCT03228901
- Acronym / sponsor ID
- IG15-B052
- Conditions
- Social Interaction
- Keywords
- Oxytocin, Affiliation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Jul 2017 (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.
In this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.
Detailed description
Using Liu et al.'s (2012) dataset, the investigators seek to observe whether the administration of oxytocin modifies non-verbal communication with a stranger.
This dataset involves a conversation between two strangers that took place 45 minutes after drug administration. While Liu et al. coded the video for markers of interpersonal distance (physical distance, eye contact, conversational intimacy), the investigators seek to analyse oxytocin's effects on non-verbal communication of affiliative and sexual cues (e.g., smiles, lip puckers). Based on findings that oxytocin's effects depend on context, the investigators will explore these relationships as a function of the conversational context (where participants converse with each other using low-, medium-, and high-intimacy topics, or in an unstructured conversation).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin24IU Syntocinon, delivered in a single nose via a nasal spray |
| Placebo | Placebo comparator | Drug: PlacebosMatched nasal spray |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (4 listed)
- pregnant;
- history of epilepsy, severe depression, severe anxiety, or psychosis;
- smoking more than 15 cigarettes a day;
- addicted to illegal substances.
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 |
|---|---|---|
| OxytocinAlso: SyntocinonAdministration of the hormone oxytocin | Drug | Oxytocin |
| Placebos | Drug | Placebo |
Primary outcome
Non-verbal communication
Time frame: Measured in the interaction which commenced 45mins after drug administration
Based on coding the video-recorded interaction between two strangers, using a coding scheme by Gonzaga et al. (for affiliative and sexual cues)
1 secondary outcome
Ratings of the person participants interacted with
Time frame: Measured following the interaction (which commenced 45 mins after drug administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Social Interaction
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Recruiting
Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (iACTforDGBI)
Disorders of Gut-brain Interaction, Distress, Psychological
RecruitingPhase 1
A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395
Healthy Adult Participants
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Social Interaction, run by Yale-NUS College at 1 site in Australia.
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 4 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: finished, as of the sponsor's last update on 27 Jul 2017. 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 Australia. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-verbal communication (time frame: Measured in the interaction which commenced 45mins after drug administration). 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 27 Jul 2017.