An interventional study of intranasal oxytocin and intranasal placebo in Healthy, sponsored by University of Electronic Science and Technology of China. Completed at 1 site in China. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-29.
Sponsored by University of Electronic Science and Technology of China · Not applicable, Interventional, and Basic science
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.
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).
Exclusion Criteria:
Subjects will first receive oxytocin (24 IU).They then will receive placebo (24 IU) 2 weeks later.
Drug: intranasal oxytocin · Drug: intranasal placebo
Subjects will first receive placebo (24 IU).They then will receive oxytocin (24 IU) 2 weeks later.
Drug: intranasal oxytocin · Drug: intranasal placebo
Each subject will be assigned to intranasal administration of oxytocin (24 IU).
An identical amount of intranasal administration of placebo will be assigned to each subject.
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.
Time frame: 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.
Time frame: 45-90 minutes after treatment administration
Perceived affective quality of the touch
Pleasantness ratings of affective touch will be compared between the oxytocin and placebo administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 45-90 minutes after treatment administration
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University of Electronic Science and Technology of China