HealthyNCT03278860
The Effects of Oxytocin on Social Touch
A study testing intranasal 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 whether intranasal oxytocin (24IU) can enhance hedonic experience and associated brain-reward reward responses to social touch. 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?
- intranasal oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2017to Oct 2019
- 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
Who cannot join
- History of brain injury
- Medical or mental illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, 611731
Qin Li, MA
About this study
Official title: The Effects of Intranasal Oxytocin on Social Touch: an fMRI-based Study
The main aim of the study is to investigate whether intranasal oxytocin (24IU) can enhance hedonic experience and associated brain-reward reward responses to social touch.
Read the detailed description
A double-blind, within-subject, placebo controlled design is employed in this study. In total 50 healthy male subjects will be recruited and they will come twice, once with the administration of oxytocin nasal spray and the other placebo (interval time is more than 2 weeks). 45 minutes after treatment subjects will be applied two different types of pleasant touch: social touch from a masseur (professional therapist) and non-social touch from a massage device. After each condition the subjects will be asked to rate pleasantness, likability, and arousal. Simultaneously functional brain activity will be acquired via fMRI. Blood samples will be taken before and after the intervention to assess oxytocin levels. All subjects were asked to complete a range of questionnaires measuring trait personality and mood: Beck Depression Inventory (BDI), Cheek and Buss Shyness Scale (CBSS),Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ), NEO Five Factor Inventory (NEO-FFI), Liebowitz Social Anxiety Scale (LSAS),Behavioral Inhibition System and Behavioral Activation System Scale (BISBAS),Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ),State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ), Sensory over Responsivity Scale (SOR) and Under Responsivity Scale (URS) one day before the first scanning. On the first and second scanning day, the subjects were asked to complete Positive and Negative Affect Schedule (PANAS) before and after treatment administration.
- Conditions
- Healthy
- Being tested
- intranasal oxytocin, intranasal placebo
- Keywords
- Oxytocin, social touch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal oxytocinDrug
24 IU of oxytocin nasal spray will be applied to each subject.
intranasal placeboDrug
an identical amount of placebo nasal spray will be applied to each subject.
intranasal oxytocinDrug
24 IU of oxytocin nasal spray will be applied to each subject.
intranasal placeboDrug
an identical amount of placebo nasal spray will be applied to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin then placebo | Experimental | Participants first received oxytocin (24 IU). After a washout period of 2 weeks, they then received placebo (24 IU). Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
| Placebo then oxytocin | Experimental | Participants first received placebo (24 IU). After a washout period of 2 weeks, they then received oxytocin (24 IU). Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural indices: fMRI-based measures of interoceptive and reward processing
fMRI-based measures of social and non-social touch-related brain activity
Measured: 45-90 minutes after treatment administration
Secondary outcomes (3)
Behavioral index: pleasantness experience
Ratings for pleasantness during the application of social and non-social touch
Measured: 45-90 minutes after treatment administration
Behavioral index: likability experience
Ratings for likability during the application of social and non-social touch
Measured: 45-90 minutes after treatment administration
Behavioral index: arousal experience
Ratings for arousal during the application of social and non-social touch
Measured: 45-90 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 posted12 Sep 2017
- Study start28 Aug 2017
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Crossover
- Model description
- Randomized placebo-controlled double-blind within-subject design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 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
- Qin Li, MA, Study chair, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278860
- Sponsor's protocol ID
- UESTC-neuSCAN-39
- Status last verified
- Oct 2018
- First submitted
- 6 Sep 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Li Q, Zhang Q, Kou J, Zhang Y, Cui H, Wernicke J, Montag C, Becker B, Kendrick KM, Yao S. The Effects of Intranasal Oxytocin on Neural and Behavioral Responses to Social Touch in the Form of Massage. Front Neurosci. 2020 Dec 4;14:589878. doi: 10.3389/fnins.2020.589878. eCollection 2020.
PubMed 33343285
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intranasal Oxytocin on Social Touch: an fMRI-based Study
- ClinicalTrials.gov ID
- NCT03278860
- Acronym / sponsor ID
- UESTC-neuSCAN-39
- Conditions
- Healthy
- Keywords
- Oxytocin, social touch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 12 Sep 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.
The main aim of the study is to investigate whether intranasal oxytocin (24IU) can enhance hedonic experience and associated brain-reward reward responses to social touch.
Detailed description
A double-blind, within-subject, placebo controlled design is employed in this study. In total 50 healthy male subjects will be recruited and they will come twice, once with the administration of oxytocin nasal spray and the other placebo (interval time is more than 2 weeks). 45 minutes after treatment subjects will be applied two different types of pleasant touch: social touch from a masseur (professional therapist) and non-social touch from a massage device. After each condition the subjects will be asked to rate pleasantness, likability, and arousal. Simultaneously functional brain activity will be acquired via fMRI. Blood samples will be taken before and after the intervention to assess oxytocin levels. All subjects were asked to complete a range of questionnaires measuring trait personality and mood: Beck Depression Inventory (BDI), Cheek and Buss Shyness Scale (CBSS),Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ), NEO Five Factor Inventory (NEO-FFI), Liebowitz Social Anxiety Scale (LSAS),Behavioral Inhibition System and Behavioral Activation System Scale (BISBAS),Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ),State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ), Sensory over Responsivity Scale (SOR) and Under Responsivity Scale (URS) one day before the first scanning. On the first and second scanning day, the subjects were asked to complete Positive and Negative Affect Schedule (PANAS) before and after treatment administration.
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 |
|---|---|---|
| Oxytocin then placebo | Experimental | Drug: intranasal oxytocin, Drug: intranasal placeboParticipants first received oxytocin (24 IU). After a washout period of 2 weeks, they then received placebo (24 IU). |
| Placebo then oxytocin | Experimental | Drug: intranasal oxytocin, Drug: intranasal placeboParticipants first received placebo (24 IU). After a washout period of 2 weeks, they then received 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
Key exclusion criteria (2 listed)
- History of brain injury
- Medical or mental illness
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 oxytocin24 IU of oxytocin nasal spray will be applied to each subject. | Drug | Oxytocin then placebo |
| intranasal placeboan identical amount of placebo nasal spray will be applied to each subject. | Drug | Oxytocin then placebo |
| intranasal oxytocin24 IU of oxytocin nasal spray will be applied to each subject. | Drug | Placebo then oxytocin |
| intranasal placeboan identical amount of placebo nasal spray will be applied to each subject. | Drug | Placebo then oxytocin |
Primary outcome
Neural indices: fMRI-based measures of interoceptive and reward processing
Time frame: 45-90 minutes after treatment administration
fMRI-based measures of social and non-social touch-related brain activity
3 secondary outcomes
Behavioral index: pleasantness experience
Time frame: 45-90 minutes after treatment administration
Behavioral index: likability experience
Time frame: 45-90 minutes after treatment administration
Behavioral index: arousal experience
Time frame: 45-90 minutes after treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 33343285Chen Y, Li Q, Zhang Q, Kou J, Zhang Y, Cui H, Wernicke J, Montag C, Becker B, Kendrick KM, Yao S. The Effects of Intranasal Oxytocin on Neural and Behavioral Responses to Social Touch in the Form of Massage. Front Neurosci. 2020 Dec 4;14:589878. doi: 10.3389/fnins.2020.589878. eCollection 2020.
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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, MA 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 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 2 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 29 Oct 2018. 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 indices: fMRI-based measures of interoceptive and reward processing (time frame: 45-90 minutes after treatment administration). 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 NCT03278860, which also lists 1 linked publication.
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 29 Oct 2018.