The Effects of Oxytocin on Affective Touch

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: intranasal oxytocin; Drug: intranasal placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611731
      • University of Electronic Science and Technology of China(UESTC)

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oxytocin then placebo; Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later.	Drug: intranasal oxytocin; Each subject will be assigned to intranasal administration of oxytocin (24 IU).; Drug: intranasal placebo; An identical amount of intranasal administration of placebo will be assigned to each subject.
EXPERIMENTAL: Placebo then oxytocin; Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later.	Drug: intranasal oxytocin; Each subject will be assigned to intranasal administration of oxytocin (24 IU).; Drug: intranasal placebo; An identical amount of intranasal administration of placebo will be assigned to each subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	45-90 minutes after treatment administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived affective quality of the touch	Pleasantness ratings of affective touch will be compared between the oxytocin and placebo administration	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	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	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	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	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	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	45-90 minutes after treatment administration

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China
• Investigators: Study Chair: Yuanshu Chen, B.S., University of Electronic Science and Technology of China

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 28, 2017
• Primary Completion (ACTUAL): January 31, 2018
• Study Completion (ACTUAL): July 12, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 13, 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: Oxytocin; affective touch; trait autism
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: UESTC-neuSCAN-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No