- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03278860
The Effects of Oxytocin on Social Touch
October 26, 2018 updated by: Keith Kendrick, University of Electronic Science and Technology of China
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- University of Electronic Science and Technology of China(UESTC)
-
Contact:
- Qin Li, MA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy subjects without any past or present psychiatric or neurological disorders
Exclusion Criteria:
- History of brain injury
- Medical or mental illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oxytocin then placebo
Participants first received oxytocin (24 IU).
After a washout period of 2 weeks, they then received placebo (24 IU).
|
24 IU of oxytocin nasal spray will be applied to each subject.
an identical amount of placebo nasal spray will be applied to each subject.
|
EXPERIMENTAL: Placebo then oxytocin
Participants first received placebo (24 IU).
After a washout period of 2 weeks, they then received oxytocin (24 IU).
|
24 IU of oxytocin nasal spray will be applied to each subject.
an identical amount of placebo nasal spray will be applied to each subject.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
45-90 minutes after treatment administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral index: pleasantness experience
Time Frame: 45-90 minutes after treatment administration
|
Ratings for pleasantness during the application of social and non-social touch
|
45-90 minutes after treatment administration
|
Behavioral index: likability experience
Time Frame: 45-90 minutes after treatment administration
|
Ratings for likability during the application of social and non-social touch
|
45-90 minutes after treatment administration
|
Behavioral index: arousal experience
Time Frame: 45-90 minutes after treatment administration
|
Ratings for arousal during the application of social and non-social touch
|
45-90 minutes after treatment administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Qin Li, MA, University of Electronic Science and Technology of China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 28, 2017
Primary Completion (ANTICIPATED)
August 1, 2019
Study Completion (ANTICIPATED)
October 1, 2019
Study Registration Dates
First Submitted
September 6, 2017
First Submitted That Met QC Criteria
September 11, 2017
First Posted (ACTUAL)
September 12, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 26, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-39
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on intranasal oxytocin
-
University of Electronic Science and Technology...Completed
-
University of NebraskaNational Institute of Mental Health (NIMH)Terminated
-
Massachusetts General HospitalUnited States Department of DefenseRecruitingAutism Spectrum Disorder | Bone HealthUnited States
-
Icahn School of Medicine at Mount SinaiRecruitingBorderline Personality DisorderUnited States
-
MacDonald, Kai, M.D.CompletedAnxiety | BehaviorUnited States
-
OptiNose ASUniversity of OsloCompletedHealthy Male AdultsNorway
-
University of Electronic Science and Technology...Recruiting
-
University of Electronic Science and Technology...Completed
-
University of Electronic Science and Technology...Completed
-
Maria de las Mercedes Perez RodriguezJames J. Peters Veterans Affairs Medical Center; VISN 3 Mental Illness Research...TerminatedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Autism Spectrum Disorder | Borderline Personality Disorder | Schizotypal Personality Disorder | SPD | BPDUnited States