Clinical trial NCT05899517: Oxytocin Effects on Self Versus Other Touch
Official title: The Effects of Orally Administered Oxytocin on Behavioral and Neural Responses to Self Versus Other Touch Distinction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Oxytocin
Affective touch
Self versus other distinction
fMRI
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 40
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 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neural index: fMRI based measures of altered neural activity in response to different types of applied touch
timeFrame: 53-75 minutes after treatment administration
measure: Behavioral index: pleasantness ratings for the different types of applied touch
timeFrame: 53-75 minutes after treatment administration
Secondary outcomes:
measure: Questionnaire scores for autistic traits using the Autism Spectrum Quotient (ASQ)
timeFrame: Before the experiment
measure: Questionnaire scores for attitudes towards touch using the Social Touch Questionnaire
timeFrame: Before the experiment
measure: Questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
timeFrame: Before the experiment
measure: Behavioral associations with autistic traits using the Autism Spectrum Quotient (ASQ)
timeFrame: Before the experiment
measure: Neural associations with autistic traits using the Autism Spectrum Quotient (ASQ)
timeFrame: Before the experiment
measure: Behavioral associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire Questionnaire (STQ)
timeFrame: Before the experiment
measure: Neural associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire (STQ)
timeFrame: Before the experiment
measure: Behavioral associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
timeFrame: Before the experiment
measure: Neural associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)
timeFrame: Before the experiment
measure: Resting state fMRI connectivity
timeFrame: 45-53 minutes after treatment
measure: Resting state fMRI connectivity association with behavioral responses to touch
timeFrame: 45-53 minutes after treatment for resting state and 53-75 minutes after treatment for behavioral measures
measure: Resting state fMRI connectivity and questionnaire scores of Autism Spectrum Quotient (ASQ) for measuring autistic traits
timeFrame: Pre-treatment for ASQ and 45-53 minutes after treatment for resting state
measure: Resting state fMRI connectivity and questionnaire scores of Social Touch Questionnaire (STQ) for measuring responses to touch
timeFrame: Pre-treatment for STQ and 45-53 minutes after treatment for resting state
measure: Resting state fMRI connectivity and questionnaire scores of Self-Concept Clarity Scale (SCCS) for measuring self-concept
timeFrame: Pre-treatment for SCCS and 45-53 minutes after treatment for resting state
Other outcomes:
Locations:
city: Sichuan
country: China
facility: University of Electronic Science and Technology of China(UESTC)
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Siying Wang, Dr.
role: STUDY_CHAIR
References: