The Effects of Oxytocin on Affective Touch

Study Overview
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Brief Summary
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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
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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).

Official Title
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Oxytocin Effects on Neural Processing of Affective Touch and Associations With Trait Autism

Conditions
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Healthy

Intervention / Treatment
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* Drug: intranasal oxytocin
* Drug: intranasal placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects without any past or present psychiatric or neurological disorders Exclusion Criteria: History of brain injury Medical or mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized placebo-controlled double-blind within-subject design
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, affective touch, trait autism