The Effects of Oxytocin on Social Touch

• Sponsor: University of Electronic Science and Technology of China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03278860
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.1
• Patients Per Site Per Month: 2

Study Details

Study Description

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; Drug: intranasal oxytocin; Drug: intranasal placebo	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized placebo-controlled double-blind within-subject designRandomized 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: Aug 28, 2017
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Neural indices: fMRI-based measures of interoceptive and reward processing [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 [45-90 minutes after treatment administration]

   Ratings for pleasantness during the application of social and non-social touch

2. Behavioral index: likability experience [45-90 minutes after treatment administration]

   Ratings for likability during the application of social and non-social touch

3. Behavioral index: arousal experience [45-90 minutes after treatment administration]

   Ratings for arousal during the application of social and non-social touch

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• History of brain injury

• Medical or mental illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Electronic Science and Technology of China(UESTC)	Chengdu	Sichuan	China	611731

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keith Kendrick, Professor, University of Electronic Science and Technology of China
• ClinicalTrials.gov Identifier: NCT03278860
• Other Study ID Numbers: UESTC-neuSCAN-39
• First Posted: Sep 12, 2017
• Last Update Posted: Oct 29, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Keith Kendrick, Professor, University of Electronic Science and Technology of China: Oxytocin; social touch
• Additional relevant MeSH terms: Oxytocin

Study Results

No Results Posted as of Oct 29, 2018