HealthyNCT05899517
Oxytocin Effects on Self Versus Other Touch
A study testing oral lollipop with oxytocin (24IU) in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- oral lollipop with oxytocin (24IU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2022to 1 Dec 2023
- Phase
- Interventional
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.
Who cannot join
- Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China(UESTC)
Sichuan
About this study
Official title: The Effects of Orally Administered Oxytocin on Behavioral and Neural Responses to Self Versus Other Touch Distinction
The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others.
Read the detailed description
In a double-blind placebo-controlled within-subject experimental design, 40 adult male subjects will be randomly allocated to either receive oral oxytocin (24IU, medicated lollipop) or placebo (lollipop without oxytocin). Starting 45 minutes after treatment a resting state functional magnetic resonance imaging (fMRI) will be recorded (8min) and next subjects will be applied two different types of stroking touch (self- vs. other-produced touch) to their left arm repeated in 16 blocks. After each block of applied touch stimulation, subjects will be required to rate their perceived pleasantness of touch from -4 (extremely unpleasant) to 4 (extremely pleasant). The neural basis of touch processing will be measured via simultaneously acquired fMRI.
To control potential confounding effects among subjects, before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality, traits, attitude towards interpersonal touch and interoceptive ability: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ),Sensory Over-Responsivity (SensOR) Scales, Interpersonal Reactivity Index (C-IRI), Self-Concept Clarity Scale (SCCS), Interoceptive Confusion Questionnaire(ICQ) and Multidimensional Assessment of Interoceptive Awareness(MAIA) scale. Additionally, to control for potential confounding effects of treatment on mood across the experiment, the Positive and Negative Affect Schedule (PANAS) will be administered immediately before and 30 minutes after the treatment. Participants will also complete the PANAS after the touch stimulations to further measure the modulatory effects of touch on mood.
- Conditions
- Healthy
- Being tested
- oral lollipop with oxytocin (24IU), oral lollipop with placebo
- Keywords
- Oxytocin, Affective touch, Self versus other distinction, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral lollipop with oxytocin (24IU)Drug
Also called oral oxytocin
For oral oxytocin administration, participants will be instructed to suck the lollipop medicated with 24IU oxytocin for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after oxytocin administration.
oral lollipop with placeboDrug
Also called oral placebo
For placebo administration, participants will be instructed to suck the placebo lollipop for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after placebo administration.
| Study group | Role | What they receive |
|---|---|---|
| Oral oxytocin then placebo | Experimental | Subjects will first receive oral lollipop with oxytocin (24IU). After a washout period of 2 weeks, they will then receive oral lollipop with placebo (identical ingredients, except the active agent). Receives: Drug: oral lollipop with oxytocin (24IU); Drug: oral lollipop with placebo |
| Oral placebo then oxytocin | Experimental | Subjects will first receive oral lollipop with placebo (identical ingredients, except the active agent). After a washout period of 2 weeks, they will then receive oral lollipop with oxytocin (24 IU). Receives: Drug: oral lollipop with oxytocin (24IU); Drug: oral lollipop with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural index: fMRI based measures of altered neural activity in response to different types of applied touch
fMRI-based indices of neural activation (blood oxygen level dependent changes) in response to repeated self vs other touch will be compared between subjects in the oxytocin and placebo administration groups.
Measured: 53-75 minutes after treatment administration
Behavioral index: pleasantness ratings for the different types of applied touch
Ratings of perceived pleasantness for the two types of repeatedly applied touch (after each block of touch, subjects will need to complete the question 'how pleasant do they feel for the applied touch?' using a 9-point Likert scale ranging from -4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be compared between the oxytocin and placebo administration groups.
Measured: 53-75 minutes after treatment administration
Secondary outcomes (14)
Questionnaire scores for autistic traits using the Autism Spectrum Quotient (ASQ)
Mean and standard deviation of the Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) will be computed as a measurement of autistic traits.
Measured: Before the experiment
Questionnaire scores for attitudes towards touch using the Social Touch Questionnaire
Mean and standard deviation of the Social Touch Questionnaire (STQ) scores (0~80, higher scores mean higher aversion to touch) will be computed to measure individual attitudes towards social touch of daily life.
Measured: Before the experiment
Questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
Mean and standard deviation of the Self-Concept Clarity Scale (SCCS) scores (0~60, higher scores mean clearer self-concept) will be computed to measure clarity level of one's self-concept.
Measured: Before the experiment
Behavioral associations with autistic traits using the Autism Spectrum Quotient (ASQ)
Associations between the Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) with behavioral rating scores (-4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be calculated to investigate modulatory effects of autistic traits.
Measured: Before the experiment
Neural associations with autistic traits using the Autism Spectrum Quotient (ASQ)
Associations between the Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) with fMRI-based indices of neural activation (blood oxygen level dependent changes) will be calculated to investigate modulatory effects of autistic traits.
Measured: Before the experiment
Behavioral associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire Questionnaire (STQ)
Associations between the Social Touch Questionnaire (STQ) scores (0~80, higher scores mean higher aversion to touch) with behavioral rating scores (-4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be calculated to investigate modulatory effects of how much subjects like being touched.
Measured: Before the experiment
Neural associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire (STQ)
Associations between the Social Touch Questionnaire (STQ) scores (0~80, higher scores mean higher aversion to touch) with fMRI-based indices of neural activation (blood oxygen level dependent changes) will be calculated to investigate modulatory effects of how much subjects like being touched.
Measured: Before the experiment
Behavioral associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
Associations between the Self-Concept Clarity Scale (SCCS) scores (0~60, higher scores mean clearer self-concept) with behavioral rating scores (-4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be calculated to investigate modulatory effects of self-concept.
Measured: Before the experiment
Neural associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
Associations between the Self-Concept Clarity Scale (SCCS) scores (0~60, higher scores mean clearer self-concept) with fMRI-based indices of neural activation (blood oxygen level dependent changes) will be calculated to investigate modulatory effects of self-concept.
Measured: Before the experiment
Resting state fMRI connectivity
The effects of oxytocin on resting state functional connectivity will be analyzed by comparing the strength of functional connections between pairs of regions using time-series signal measures (-1 to +1 with greater positive values indicating stronger functional connectivity) in subjects in the oxytocin and placebo treatment groups.
Measured: 45-53 minutes after treatment
Resting state fMRI connectivity association with behavioral responses to touch
Associations between resting state fMRI connectivity and primary outcome measures will be calculated to investigate whether resting state functional connectivity is predictive of observed treatment effects on individual behavioral responses (behavioral rating scores: -4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) to touch.
Measured: 45-53 minutes after treatment for resting state and 53-75 minutes after treatment for behavioral measures
Resting state fMRI connectivity and questionnaire scores of Autism Spectrum Quotient (ASQ) for measuring autistic traits
Associations between resting state fMRI connectivity and Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) will be calculated to investigate whether resting state functional connectivity is predictive of individual autistic traits.
Measured: Pre-treatment for ASQ and 45-53 minutes after treatment for resting state
Resting state fMRI connectivity and questionnaire scores of Social Touch Questionnaire (STQ) for measuring responses to touch
Associations between resting state fMRI connectivity and Social Touch Questionnaire (STQ) scores (0~80, higher scores mean higher aversion to touch) will be calculated to investigate whether resting state functional connectivity is predictive of how much subjects like being touched.
Measured: Pre-treatment for STQ and 45-53 minutes after treatment for resting state
Resting state fMRI connectivity and questionnaire scores of Self-Concept Clarity Scale (SCCS) for measuring self-concept
Associations between resting state fMRI connectivity and Self-Concept Clarity Scale (SCCS) scores (0~60, higher scores mean clearer self-concept) will be calculated to investigate whether resting state functional connectivity is predictive of self-concept.
Measured: Pre-treatment for SCCS and 45-53 minutes after treatment for resting state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start22 Jun 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized placebo-controlled double-blind within-subject design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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
- Investigators
- Siying Wang, Dr., Study chair, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899517
- Sponsor's protocol ID
- UESTC-neuSCAN-92
- Status last verified
- Jun 2023
- First submitted
- 5 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Orally Administered Oxytocin on Behavioral and Neural Responses to Self Versus Other Touch Distinction
- ClinicalTrials.gov ID
- NCT05899517
- Acronym / sponsor ID
- UESTC-neuSCAN-92
- Conditions
- Healthy
- Keywords
- Oxytocin, Affective touch, Self versus other distinction, fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Jun 2023 (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 study is to investigate the modulatory effects of oxytocin (24IU) administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others.
Detailed description
In a double-blind placebo-controlled within-subject experimental design, 40 adult male subjects will be randomly allocated to either receive oral oxytocin (24IU, medicated lollipop) or placebo (lollipop without oxytocin). Starting 45 minutes after treatment a resting state functional magnetic resonance imaging (fMRI) will be recorded (8min) and next subjects will be applied two different types of stroking touch (self- vs. other-produced touch) to their left arm repeated in 16 blocks. After each block of applied touch stimulation, subjects will be required to rate their perceived pleasantness of touch from -4 (extremely unpleasant) to 4 (extremely pleasant). The neural basis of touch processing will be measured via simultaneously acquired fMRI.
To control potential confounding effects among subjects, before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality, traits, attitude towards interpersonal touch and interoceptive ability: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ),Sensory Over-Responsivity (SensOR) Scales, Interpersonal Reactivity Index (C-IRI), Self-Concept Clarity Scale (SCCS), Interoceptive Confusion Questionnaire(ICQ) and Multidimensional Assessment of Interoceptive Awareness(MAIA) scale. Additionally, to control for potential confounding effects of treatment on mood across the experiment, the Positive and Negative Affect Schedule (PANAS) will be administered immediately before and 30 minutes after the treatment. Participants will also complete the PANAS after the touch stimulations to further measure the modulatory effects of touch on mood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled double-blind within-subject design
| Arm | Type | Receives |
|---|---|---|
| Oral oxytocin then placebo | Experimental | Drug: oral lollipop with oxytocin (24IU), Drug: oral lollipop with placeboSubjects will first receive oral lollipop with oxytocin (24IU). After a washout period of 2 weeks, they will then receive oral lollipop with placebo (identical ingredients, except the active agent). |
| Oral placebo then oxytocin | Experimental | Drug: oral lollipop with oxytocin (24IU), Drug: oral lollipop with placeboSubjects will first receive oral lollipop with placebo (identical ingredients, except the active agent). After a washout period of 2 weeks, they will then receive oral lollipop with oxytocin (24 IU). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.
Key exclusion criteria (1 listed)
- Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.
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 |
|---|---|---|
| oral lollipop with oxytocin (24IU)Also: oral oxytocinFor oral oxytocin administration, participants will be instructed to suck the lollipop medicated with 24IU oxytocin for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after oxytocin administration. | Drug | Oral oxytocin then placebo, Oral placebo then oxytocin |
| oral lollipop with placeboAlso: oral placeboFor placebo administration, participants will be instructed to suck the placebo lollipop for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after placebo administration. | Drug | Oral oxytocin then placebo, Oral placebo then oxytocin |
Primary outcome
Neural index: fMRI based measures of altered neural activity in response to different types of applied touch
Time frame: 53-75 minutes after treatment administration
fMRI-based indices of neural activation (blood oxygen level dependent changes) in response to repeated self vs other touch will be compared between subjects in the oxytocin and placebo administration groups.
Behavioral index: pleasantness ratings for the different types of applied touch
Time frame: 53-75 minutes after treatment administration
Ratings of perceived pleasantness for the two types of repeatedly applied touch (after each block of touch, subjects will need to complete the question 'how pleasant do they feel for the applied touch?' using a 9-point Likert scale ranging from -4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be compared between the oxytocin and placebo administration groups.
14 secondary outcomes
Questionnaire scores for autistic traits using the Autism Spectrum Quotient (ASQ)
Time frame: Before the experiment
Questionnaire scores for attitudes towards touch using the Social Touch Questionnaire
Time frame: Before the experiment
Questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
Time frame: Before the experiment
Behavioral associations with autistic traits using the Autism Spectrum Quotient (ASQ)
Time frame: Before the experiment
Neural associations with autistic traits using the Autism Spectrum Quotient (ASQ)
Time frame: Before the experiment
Behavioral associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire Questionnaire (STQ)
Time frame: Before the experiment
Neural associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire (STQ)
Time frame: Before the experiment
Behavioral associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
Time frame: Before the experiment
Neural associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
Time frame: Before the experiment
Resting state fMRI connectivity
Time frame: 45-53 minutes after treatment
Resting state fMRI connectivity association with behavioral responses to touch
Time frame: 45-53 minutes after treatment for resting state and 53-75 minutes after treatment for behavioral measures
Resting state fMRI connectivity and questionnaire scores of Autism Spectrum Quotient (ASQ) for measuring autistic traits
Time frame: Pre-treatment for ASQ and 45-53 minutes after treatment for resting state
Resting state fMRI connectivity and questionnaire scores of Social Touch Questionnaire (STQ) for measuring responses to touch
Time frame: Pre-treatment for STQ and 45-53 minutes after treatment for resting state
Resting state fMRI connectivity and questionnaire scores of Self-Concept Clarity Scale (SCCS) for measuring self-concept
Time frame: Pre-treatment for SCCS and 45-53 minutes after treatment for resting state
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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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. This study is not recruiting at the moment.
Siying Wang, Dr. study chair
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral lollipop with oxytocin (24IU) in people with Healthy, 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 1 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith M Kendrick, Dr. (+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?
Neural index: fMRI based measures of altered neural activity in response to different types of applied touch (time frame: 53-75 minutes after treatment administration). 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 12 Jun 2023.