HealthyNCT05265806
The Effects of Oxytocin Treatment on Social Touch
A study testing Intranasal oxytocin and Oral oxytocin 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) administration on the affective processing of touch manipulated differently in gentle caress-like stroke vs. social massage with a moderate pressure. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intranasal oxytocin and Oral oxytocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 25 May 2022
- 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
- All sexes
- 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
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, 611731
About this study
Official title: The Effects of Oxytocin on Social Touch: an fNIRS-based Study
The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administration on the affective processing of touch manipulated differently in gentle caress-like stroke vs. social massage with a moderate pressure.
Read the detailed description
A randomized double-blind placebo-controlled mixed experimental design with three arms (intranasal oxytocin administration vs. oral oxytocin administration vs. placebo administration, each with 60 subjects) will be employed in the current study. 35 minutes after treatment subjects will be applied two different types of pleasant touch (social massage vs. caress-like stroking) to their calf. After each applied touch stimulation session, the subjects will be asked to rate their subjective experience of the touch including the perceived pleasantness, arousal, intensity and payment. The neural basis of touch processing will be measured via simultaneously acquired fNIRS together with skin conductance responses and the electrocardiogram recording. Blood samples will be taken before and after the treatment as well as after each run session to measure plasma oxytocin levels to explore the associations with primary outcome measure (the behavioral and neural measures of touch processing). Mixed-measure analysis of variance (ANOVA) with treatment as between-subject factor and condition as within-subject factor will be used to investigate oxytocin effects on social touch processing.
To control potential confounding effects across groups, 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 sensitivity to reward: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), the Cheek and Buss Shyness Scale (CBSS), the Adult Attachment Scale (AAS), the Childhood Trauma Questionnaire (CTQ), social touch questionnaire (STQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Sensory Over-Responsivity (SensOR) Scales and the Interpersonal Reactivity Index (C-IRI). And associations between questionnaire scores (especially the ASQ and STQ scores) with primary outcome measure will be explored to investigate modulatory effects of autistic traits. 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 each type of touch condition to further measure the modulatory effects of stroking touch and massage on mood.
- Conditions
- Healthy
- Being tested
- Intranasal oxytocin, Oral oxytocin, Placebo
- Keywords
- Oxytocin, Social touch, fNIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal oxytocinDrug
Also called Oxytocin intranasal spray
Each subject will be assigned to administration of oxytocin intranasal spray (24 IU).
Oral oxytocinDrug
Also called Oxytocin lingual spray
Each subject will be assigned to administration of oxytocin lingual spray (24 IU).
PlaceboDrug
Also called PLC
An identical amount of intranasal administration of placebo (identical ingredients except the peptide - i.e. glycerine and sodium chloride) will be assigned to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal oxytocin | Experimental | Participants will be randomly assigned to the administration of oxytocin intranasal spray (24 IU). Receives: Drug: Intranasal oxytocin |
| Oral oxytocin | Experimental | Participants will be randomly assigned to the administration of oxytocin lingual spray (24 IU). Receives: Drug: Oral oxytocin |
| Placebo | Placebo comparator | Participants will be randomly assigned to the administration of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural index: fNIRS based measures of touch processing
fNIRS-based indices of neural processing of social touch after the oxytocin and placebo administration in response to each experimental condition.
Measured: 35-90 minutes after treatment administration
Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch
Ratings of perceived pleasantness, arousal, intensity and the willing to pay for the applied caress-like touch and massage after the oxytocin and placebo administration.
Measured: 50-90 minutes after treatment administration
Secondary outcomes (5)
Plasma oxytocin concentration
Basal and altered blood oxytocin concentrations for different treatment groups before and 30 minutes after the administration as well as after each touch condition.
Measured: Basal concentration before treatment and altered level during 30-90 minutes after treatment administration
Electrophysiological index: skin conductance responses (SCR)
SCR amplitudes during touch processing to further investigate oxytocin effects on each experimental condition compared with the placebo.
Measured: 35-90 minutes after treatment administration
Electrophysiological index: heart rate variability (HRV)
HRV reflecting the variability in consecutive heartbeats calculated from electrocardiography during touch processing to further investigate oxytocin effects on each experimental condition compared with the placebo.
Measured: 35-90 minutes after treatment administration
Questionnaire scores of autistic traits
The Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) to investigate modulatory effects of autistic traits.
Measured: Before the experiment
Gender difference in the neural and behavioral index
Gender difference in the neural and behavioral response during the touch processing for different treatment groups.
Measured: 35-90 minutes after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- Randomized placebo-controlled double-blind mixed experimental design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
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
- Qin Li, Dr., Study chair, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265806
- Sponsor's protocol ID
- UESTC-neuSCAN-79
- Status last verified
- May 2023
- First submitted
- 20 Feb 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yamagata T, Ogiwara I, Tatsukawa T, Suzuki T, Otsuka Y, Imaeda N, Mazaki E, Inoue I, Tokonami N, Hibi Y, Itohara S, Yamakawa K. Scn1a-GFP transgenic mouse revealed Nav1.1 expression in neocortical pyramidal tract projection neurons. Elife. 2023 May 23;12:e87495. doi: 10.7554/eLife.87495.
PubMed 37219072Chen Y, Zou H, Hou X, Lan C, Wang J, Qing Y, Chen W, Yao S, Kendrick KM. Oxytocin administration enhances pleasantness and neural responses to gentle stroking but not moderate pressure social touch by increasing peripheral concentrations. Elife. 2023 May 12;12:e85847. doi: 10.7554/eLife.85847.
PubMed 37171081
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oxytocin on Social Touch: an fNIRS-based Study
- ClinicalTrials.gov ID
- NCT05265806
- Acronym / sponsor ID
- UESTC-neuSCAN-79
- Conditions
- Healthy
- Keywords
- Oxytocin, Social touch, fNIRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 4 Mar 2022 (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) administration on the affective processing of touch manipulated differently in gentle caress-like stroke vs. social massage with a moderate pressure.
Detailed description
A randomized double-blind placebo-controlled mixed experimental design with three arms (intranasal oxytocin administration vs. oral oxytocin administration vs. placebo administration, each with 60 subjects) will be employed in the current study. 35 minutes after treatment subjects will be applied two different types of pleasant touch (social massage vs. caress-like stroking) to their calf. After each applied touch stimulation session, the subjects will be asked to rate their subjective experience of the touch including the perceived pleasantness, arousal, intensity and payment. The neural basis of touch processing will be measured via simultaneously acquired fNIRS together with skin conductance responses and the electrocardiogram recording. Blood samples will be taken before and after the treatment as well as after each run session to measure plasma oxytocin levels to explore the associations with primary outcome measure (the behavioral and neural measures of touch processing). Mixed-measure analysis of variance (ANOVA) with treatment as between-subject factor and condition as within-subject factor will be used to investigate oxytocin effects on social touch processing.
To control potential confounding effects across groups, 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 sensitivity to reward: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), the Cheek and Buss Shyness Scale (CBSS), the Adult Attachment Scale (AAS), the Childhood Trauma Questionnaire (CTQ), social touch questionnaire (STQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Sensory Over-Responsivity (SensOR) Scales and the Interpersonal Reactivity Index (C-IRI). And associations between questionnaire scores (especially the ASQ and STQ scores) with primary outcome measure will be explored to investigate modulatory effects of autistic traits. 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 each type of touch condition to further measure the modulatory effects of stroking touch and massage on mood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized placebo-controlled double-blind mixed experimental design
| Arm | Type | Receives |
|---|---|---|
| Intranasal oxytocin | Experimental | Drug: Intranasal oxytocinParticipants will be randomly assigned to the administration of oxytocin intranasal spray (24 IU). |
| Oral oxytocin | Experimental | Drug: Oral oxytocinParticipants will be randomly assigned to the administration of oxytocin lingual spray (24 IU). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomly assigned to the administration of placebo. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- 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 |
|---|---|---|
| Intranasal oxytocinAlso: Oxytocin intranasal sprayEach subject will be assigned to administration of oxytocin intranasal spray (24 IU). | Drug | Intranasal oxytocin |
| Oral oxytocinAlso: Oxytocin lingual sprayEach subject will be assigned to administration of oxytocin lingual spray (24 IU). | Drug | Oral oxytocin |
| PlaceboAlso: PLCAn identical amount of intranasal administration of placebo (identical ingredients except the peptide - i.e. glycerine and sodium chloride) will be assigned to each subject. | Drug | Placebo |
Primary outcome
Neural index: fNIRS based measures of touch processing
Time frame: 35-90 minutes after treatment administration
fNIRS-based indices of neural processing of social touch after the oxytocin and placebo administration in response to each experimental condition.
Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch
Time frame: 50-90 minutes after treatment administration
Ratings of perceived pleasantness, arousal, intensity and the willing to pay for the applied caress-like touch and massage after the oxytocin and placebo administration.
5 secondary outcomes
Plasma oxytocin concentration
Time frame: Basal concentration before treatment and altered level during 30-90 minutes after treatment administration
Electrophysiological index: skin conductance responses (SCR)
Time frame: 35-90 minutes after treatment administration
Electrophysiological index: heart rate variability (HRV)
Time frame: 35-90 minutes after treatment administration
Questionnaire scores of autistic traits
Time frame: Before the experiment
Gender difference in the neural and behavioral index
Time frame: 35-90 minutes after treatment 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 11 May 2023.
- Derived from this study: PubMed 37219072Yamagata T, Ogiwara I, Tatsukawa T, Suzuki T, Otsuka Y, Imaeda N, Mazaki E, Inoue I, Tokonami N, Hibi Y, Itohara S, Yamakawa K. Scn1a-GFP transgenic mouse revealed Nav1.1 expression in neocortical pyramidal tract projection neurons. Elife. 2023 May 23;12:e87495. doi: 10.7554/eLife.87495.
- Derived from this study: PubMed 37171081Chen Y, Zou H, Hou X, Lan C, Wang J, Qing Y, Chen W, Yao S, Kendrick KM. Oxytocin administration enhances pleasantness and neural responses to gentle stroking but not moderate pressure social touch by increasing peripheral concentrations. Elife. 2023 May 12;12:e85847. doi: 10.7554/eLife.85847.
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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.
Qin Li, 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 Intranasal oxytocin and Oral oxytocin 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: finished, as of the sponsor's last update on 11 May 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. 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.
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?
Neural index: fNIRS based measures of touch processing (time frame: 35-90 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?
On the ClinicalTrials.gov record for NCT05265806, which also lists 2 linked publications.
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 11 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.