Oxytocin Effects on Self Versus Other Touch

Study Overview
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Brief Summary
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The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others.

Detailed Description
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In a double-blind placebo-controlled within-subject experimental design, 40 adult male subjects will be randomly allocated to either receive oral oxytocin (24IU, medicated lollipop) or placebo (lollipop without oxytocin). Starting 45 minutes after treatment a resting state functional magnetic resonance imaging (fMRI) will be recorded (8min) and next subjects will be applied two different types of stroking touch (self- vs. other-produced touch) to their left arm repeated in 16 blocks. After each block of applied touch stimulation, subjects will be required to rate their perceived pleasantness of touch from -4 (extremely unpleasant) to 4 (extremely pleasant). The neural basis of touch processing will be measured via simultaneously acquired fMRI. To control potential confounding effects among subjects, before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality, traits, attitude towards interpersonal touch and interoceptive ability: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ),Sensory Over-Responsivity (SensOR) Scales, Interpersonal Reactivity Index (C-IRI), Self-Concept Clarity Scale (SCCS), Interoceptive Confusion Questionnaire(ICQ) and Multidimensional Assessment of Interoceptive Awareness(MAIA) scale. Additionally, to control for potential confounding effects of treatment on mood across the experiment, the Positive and Negative Affect Schedule (PANAS) will be administered immediately before and 30 minutes after the treatment. Participants will also complete the PANAS after the touch stimulations to further measure the modulatory effects of touch on mood.

Official Title
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The Effects of Orally Administered Oxytocin on Behavioral and Neural Responses to Self Versus Other Touch Distinction

Conditions
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Healthy

Intervention / Treatment
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* Drug: oral lollipop with oxytocin (24IU)
* Drug: oral lollipop with 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 and without any current psychotherapeutic medication. Exclusion Criteria: Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.

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: Oral oxytocin then placebo<br>Subjects will first receive oral lollipop with oxytocin (24IU). After a washout period of 2 weeks, they will then receive oral lollipop with placebo (identical ingredients, except the active agent). | Drug: oral lollipop with oxytocin (24IU)<br>* For oral oxytocin administration, participants will be instructed to suck the lollipop medicated with 24IU oxytocin for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after oxytocin administration.<br>* Other names: oral oxytocin;Drug: oral lollipop with placebo<br>* For placebo administration, participants will be instructed to suck the placebo lollipop for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after placebo administration.<br>* Other names: oral placebo;|
| Experimental: Oral placebo then oxytocin<br>Subjects will first receive oral lollipop with placebo (identical ingredients, except the active agent). After a washout period of 2 weeks, they will then receive oral lollipop with oxytocin (24 IU). | Drug: oral lollipop with oxytocin (24IU)<br>* For oral oxytocin administration, participants will be instructed to suck the lollipop medicated with 24IU oxytocin for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after oxytocin administration.<br>* Other names: oral oxytocin;Drug: oral lollipop with placebo<br>* For placebo administration, participants will be instructed to suck the placebo lollipop for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to rate their mood (PANAS). Participants then start the self versus other touch task around 53 minutes after placebo administration.<br>* Other names: oral placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural index: fMRI based measures of altered neural activity in response to different types of applied touch | fMRI-based indices of neural activation (blood oxygen level dependent changes) in response to repeated self vs other touch will be compared between subjects in the oxytocin and placebo administration groups. | 53-75 minutes after treatment administration | 
| Behavioral index: pleasantness ratings for the different types of applied touch | Ratings of perceived pleasantness for the two types of repeatedly applied touch (after each block of touch, subjects will need to complete the question 'how pleasant do they feel for the applied touch?' using a 9-point Likert scale ranging from -4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be compared between the oxytocin and placebo administration groups. | 53-75 minutes after treatment administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire scores for autistic traits using the Autism Spectrum Quotient (ASQ) | Mean and standard deviation of the Autism Spectrum Quotient (ASQ) scores (0 50, higher scores mean higher autistic trait) will be computed as a measurement of autistic traits. | Before the experiment | 
| Questionnaire scores for attitudes towards touch using the Social Touch Questionnaire | Mean and standard deviation of the Social Touch Questionnaire (STQ) scores (0 80, higher scores mean higher aversion to touch) will be computed to measure individual attitudes towards social touch of daily life. | Before the experiment | 
| Questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS) | Mean and standard deviation of the Self-Concept Clarity Scale (SCCS) scores (0 60, higher scores mean clearer self-concept) will be computed to measure clarity level of one's self-concept. | Before the experiment | 
| Behavioral associations with autistic traits using the Autism Spectrum Quotient (ASQ) | Associations between the Autism Spectrum Quotient (ASQ) scores (0 50, higher scores mean higher autistic trait) with behavioral rating scores (-4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be calculated to investigate modulatory effects of autistic traits. | Before the experiment | 
| Neural associations with autistic traits using the Autism Spectrum Quotient (ASQ) | Associations between the Autism Spectrum Quotient (ASQ) scores (0 50, higher scores mean higher autistic trait) with fMRI-based indices of neural activation (blood oxygen level dependent changes) will be calculated to investigate modulatory effects of autistic traits. | Before the experiment | 
| Behavioral associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire Questionnaire (STQ) | Associations between the Social Touch Questionnaire (STQ) scores (0 80, higher scores mean higher aversion to touch) with behavioral rating scores (-4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be calculated to investigate modulatory effects of how much subjects like being touched. | Before the experiment | 
| Neural associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire (STQ) | Associations between the Social Touch Questionnaire (STQ) scores (0 80, higher scores mean higher aversion to touch) with fMRI-based indices of neural activation (blood oxygen level dependent changes) will be calculated to investigate modulatory effects of how much subjects like being touched. | Before the experiment | 
| Behavioral associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS) | Associations between the Self-Concept Clarity Scale (SCCS) scores (0 60, higher scores mean clearer self-concept) with behavioral rating scores (-4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be calculated to investigate modulatory effects of self-concept. | Before the experiment | 
| Neural associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS) | Associations between the Self-Concept Clarity Scale (SCCS) scores (0 60, higher scores mean clearer self-concept) with fMRI-based indices of neural activation (blood oxygen level dependent changes) will be calculated to investigate modulatory effects of self-concept. | Before the experiment | 
| Resting state fMRI connectivity | The effects of oxytocin on resting state functional connectivity will be analyzed by comparing the strength of functional connections between pairs of regions using time-series signal measures (-1 to +1 with greater positive values indicating stronger functional connectivity) in subjects in the oxytocin and placebo treatment groups. | 45-53 minutes after treatment | 
| Resting state fMRI connectivity association with behavioral responses to touch | Associations between resting state fMRI connectivity and primary outcome measures will be calculated to investigate whether resting state functional connectivity is predictive of observed treatment effects on individual behavioral responses (behavioral rating scores: -4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) to touch. | 45-53 minutes after treatment for resting state and 53-75 minutes after treatment for behavioral measures | 
| Resting state fMRI connectivity and questionnaire scores of Autism Spectrum Quotient (ASQ) for measuring autistic traits | Associations between resting state fMRI connectivity and Autism Spectrum Quotient (ASQ) scores (0 50, higher scores mean higher autistic trait) will be calculated to investigate whether resting state functional connectivity is predictive of individual autistic traits. | Pre-treatment for ASQ and 45-53 minutes after treatment for resting state | 
| Resting state fMRI connectivity and questionnaire scores of Social Touch Questionnaire (STQ) for measuring responses to touch | Associations between resting state fMRI connectivity and Social Touch Questionnaire (STQ) scores (0 80, higher scores mean higher aversion to touch) will be calculated to investigate whether resting state functional connectivity is predictive of how much subjects like being touched. | Pre-treatment for STQ and 45-53 minutes after treatment for resting state | 
| Resting state fMRI connectivity and questionnaire scores of Self-Concept Clarity Scale (SCCS) for measuring self-concept | Associations between resting state fMRI connectivity and Self-Concept Clarity Scale (SCCS) scores (0 60, higher scores mean clearer self-concept) will be calculated to investigate whether resting state functional connectivity is predictive of self-concept. | Pre-treatment for SCCS and 45-53 minutes after treatment for resting state | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, Affective touch, Self versus other distinction, fMRI