HealthyNCT03282162
The Effects of Oxytocin on Affective 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) increases the affective processing of touch in general or whether it's effect vary according to the affective valence of the touch (positive, neutral, negative). Moreover, associations with trait autism will be explored. 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 12 Jul 2018
- 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
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, 611731
About this study
Official title: Oxytocin Effects on Neural Processing of Affective Touch and Associations With Trait Autism
The main aim of the study is to investigate whether intranasal oxytocin (24IU) increases the affective processing of touch in general or whether it's effect vary according to the affective valence of the touch (positive, neutral, negative). Moreover, associations with trait autism will be explored.
Read the detailed description
A double-blind, within-subject, placebo controlled design will be employed in this study. In a randomized-order a total of 40 healthy male subjects will receive oxytocin- and placebo-nasalspray (interval between the administration > 2 weeks). 45 minutes after treatment subjects will be administered the touch-stimulation to the dorsal forearm by a trained experimenter (lengths: 8cm, rate 8cm/s). After each block of stimulation, the subjects will be asked to rate their subjective experience of the touch.The neural basis of touch processing will be measured via simultaneously acquired fMRI.
Levels of trait autism will be assessed using the Autism Spectrum Quotient (ASQ) and related scales such as the Empathy Quotient (EQ), Liebowitz Social Anxiety Scale (LSAS), or the Sensory over Responsivity Scale (SOR) and Under Responsively Scale (URS).
- Conditions
- Healthy
- Being tested
- intranasal oxytocin, intranasal placebo
- Keywords
- Oxytocin, affective touch, trait autism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal oxytocinDrug
Each subject will be assigned to intranasal administration of oxytocin (24 IU).
intranasal placeboDrug
An identical amount of intranasal administration of placebo will be assigned to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin then placebo | Experimental | Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later. Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
| Placebo then oxytocin | Experimental | Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later. Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain function: neural activity during affective touch as assessed via BOLD fMRI
fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin neural activity following oxytocin administration will be compared with neural activity following placebo administration.
Measured: 45-90 minutes after treatment administration
Brain function: functional connectivity during affective touch as assessed via BOLD fMRI
fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin on the brain network level, functional connectivity following oxytocin administration will be compared with functional connectivity following placebo administration.
Measured: 45-90 minutes after treatment administration
Secondary outcomes (7)
Perceived affective quality of the touch
Pleasantness ratings of affective touch will be compared between the oxytocin and placebo administration
Measured: 45-90 minutes after treatment administration
Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity
Associations between individual differences in trait autism and brain activity differences between the oxytocin and placebo administration will be examined
Measured: 45-90 minutes after treatment administration
Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity
Associations between individual differences in trait autism and brain connectivity differences between the oxytocin and placebo administration will be examined
Measured: 45-90 minutes after treatment administration
Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience
Associations between individual differences in trait autism and differences in pleasantness ratings between the oxytocin and placebo administration will be examined
Measured: 45-90 minutes after treatment administration
Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity
Associations between individual differences in Sensory Responsivity as assessed via the Sensory Responsivity Scale and brain activity differences between the oxytocin and placebo administration will be examined
Measured: 45-90 minutes after treatment administration
Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity
Associations between individual differences in Sensory Responsivity as assessed via the Sensory Responsivity Scale and brain connectivity differences between the oxytocin and placebo administration will be examined
Measured: 45-90 minutes after treatment administration
Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - behaviour: pleasantness experience
Associations between individual differences in Sensory Responsivity as assessed via the Sensory Responsivity Scale and differences in pleasantness ratings between the oxytocin and placebo administration will be examined
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 posted13 Sep 2017
- Study start28 Aug 2017
- Primary completion31 Jan 2018
- Study completion12 Jul 2018
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
- 50 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
- Yuanshu Chen, B.S., Study chair, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282162
- Sponsor's protocol ID
- UESTC-neuSCAN-40
- Status last verified
- Oct 2018
- First submitted
- 7 Sep 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Oxytocin Effects on Neural Processing of Affective Touch and Associations With Trait Autism
- ClinicalTrials.gov ID
- NCT03282162
- Acronym / sponsor ID
- UESTC-neuSCAN-40
- Conditions
- Healthy
- Keywords
- Oxytocin, affective touch, trait autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 13 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) increases the affective processing of touch in general or whether it's effect vary according to the affective valence of the touch (positive, neutral, negative). Moreover, associations with trait autism will be explored.
Detailed description
A double-blind, within-subject, placebo controlled design will be employed in this study. In a randomized-order a total of 40 healthy male subjects will receive oxytocin- and placebo-nasalspray (interval between the administration > 2 weeks). 45 minutes after treatment subjects will be administered the touch-stimulation to the dorsal forearm by a trained experimenter (lengths: 8cm, rate 8cm/s). After each block of stimulation, the subjects will be asked to rate their subjective experience of the touch.The neural basis of touch processing will be measured via simultaneously acquired fMRI.
Levels of trait autism will be assessed using the Autism Spectrum Quotient (ASQ) and related scales such as the Empathy Quotient (EQ), Liebowitz Social Anxiety Scale (LSAS), or the Sensory over Responsivity Scale (SOR) and Under Responsively Scale (URS).
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 placeboSubjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later. |
| Placebo then oxytocin | Experimental | Drug: intranasal oxytocin, Drug: intranasal placeboSubjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later. |
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 (1 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 oxytocinEach subject will be assigned to intranasal administration of oxytocin (24 IU). | Drug | Oxytocin then placebo, Placebo then oxytocin |
| intranasal placeboAn identical amount of intranasal administration of placebo will be assigned to each subject. | Drug | Oxytocin then placebo, Placebo then oxytocin |
Primary outcome
brain function: neural activity during affective touch as assessed via BOLD fMRI
Time frame: 45-90 minutes after treatment administration
fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin neural activity following oxytocin administration will be compared with neural activity following placebo administration.
Brain function: functional connectivity during affective touch as assessed via BOLD fMRI
Time frame: 45-90 minutes after treatment administration
fMRI data will be analyzed using a within-subject General Linear Model approach - to determine the effects of oxytocin on the brain network level, functional connectivity following oxytocin administration will be compared with functional connectivity following placebo administration.
7 secondary outcomes
Perceived affective quality of the touch
Time frame: 45-90 minutes after treatment administration
Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity
Time frame: 45-90 minutes after treatment administration
Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity
Time frame: 45-90 minutes after treatment administration
Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience
Time frame: 45-90 minutes after treatment administration
Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity
Time frame: 45-90 minutes after treatment administration
Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity
Time frame: 45-90 minutes after treatment administration
Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - behaviour: pleasantness experience
Time frame: 45-90 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 29 Oct 2018.
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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.
Yuanshu Chen, B.S. 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 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 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?
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?
brain function: neural activity during affective touch as assessed via BOLD fMRI (time frame: 45-90 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?
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.