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The Effects of Oxytocin on Social Touch

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ClinicalTrials.gov Identifier: NCT03278860
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Keith Kendrick, University of Electronic Science and Technology of China

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: intranasal oxytocin Drug: intranasal placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized placebo-controlled double-blind within-subject design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Intranasal Oxytocin on Social Touch: an fMRI-based Study
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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).
Drug: intranasal oxytocin
24 IU of oxytocin nasal spray will be applied to each subject.

Drug: intranasal placebo
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).
Drug: intranasal oxytocin
24 IU of oxytocin nasal spray will be applied to each subject.

Drug: intranasal placebo
an identical amount of placebo nasal spray will be applied to each subject.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Behavioral index: pleasantness experience [ Time Frame: 45-90 minutes after treatment administration ]
    Ratings for pleasantness during the application of social and non-social touch

  2. Behavioral index: likability experience [ Time Frame: 45-90 minutes after treatment administration ]
    Ratings for likability during the application of social and non-social touch

  3. Behavioral index: arousal experience [ Time Frame: 45-90 minutes after treatment administration ]
    Ratings for arousal during the application of social and non-social touch



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

  • History of brain injury
  • Medical or mental illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278860


Contacts
Contact: Keith M Kendrick, Dr. 86-28-61830811 k.kendrick.uestc@gmail.com
Contact: Benjamin Becker, Dr. 86-28-61830988 ben_becker@gmx.de

Locations
China, Sichuan
University of Electronic Science and Technology of China(UESTC) Recruiting
Chengdu, Sichuan, China, 611731
Contact: Qin Li, MA         
Sponsors and Collaborators
University of Electronic Science and Technology of China
Investigators
Study Chair: Qin Li, MA University of Electronic Science and Technology of China

Responsible Party: Keith Kendrick, Professor, University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT03278860     History of Changes
Other Study ID Numbers: UESTC-neuSCAN-39
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Keith Kendrick, University of Electronic Science and Technology of China:
Oxytocin
social touch

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs