Clinical trial NCT03282162: The Effects of Oxytocin on Affective Touch
Official title: Oxytocin Effects on Neural Processing of Affective Touch and Associations With Trait Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Oxytocin
affective touch
trait autism
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized placebo-controlled double-blind within-subject design
Primary purpose: BASIC_SCIENCE

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* History of brain injury Medical or mental illness

Primary outcomes:
measure: brain function: neural activity during affective touch as assessed via BOLD fMRI
timeFrame: 45-90 minutes after treatment administration
measure: Brain function: functional connectivity during affective touch as assessed via BOLD fMRI
timeFrame: 45-90 minutes after treatment administration
Secondary outcomes:
measure: Perceived affective quality of the touch
timeFrame: 45-90 minutes after treatment administration
measure: Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: activity
timeFrame: 45-90 minutes after treatment administration
measure: Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - brain function: functional connectivity
timeFrame: 45-90 minutes after treatment administration
measure: Associations with trait autism as assessed via the Autism-Spectrum Quotient (AQ) - behaviour: pleasantness experience
timeFrame: 45-90 minutes after treatment administration
measure: Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: activity
timeFrame: 45-90 minutes after treatment administration
measure: Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - brain function: functional connectivity
timeFrame: 45-90 minutes after treatment administration
measure: Associations with Sensory Responsivity as assessed via the Sensory Responsivity Scale - behaviour: pleasantness experience
timeFrame: 45-90 minutes after treatment administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China(UESTC)
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Yuanshu Chen, B.S.
role: STUDY_CHAIR
References: