Oxytocin Effects on Self Versus Other Touch

NCT ID: NCT05899517

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2023-12-01

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Oral oxytocin then placebo

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).

Group Type: EXPERIMENTAL

oral lollipop with oxytocin (24IU)

Intervention Type: DRUG

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.

oral lollipop with placebo

Intervention Type: DRUG

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.

Oral placebo then oxytocin

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).

Group Type: EXPERIMENTAL

oral lollipop with oxytocin (24IU)

Intervention Type: DRUG

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.

oral lollipop with placebo

Intervention Type: DRUG

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.

Interventions

oral lollipop with oxytocin (24IU)

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.

Intervention Type: DRUG

oral lollipop with placebo

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.

Intervention Type: DRUG

Other Intervention Names

oral oxytocin; oral placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Keith Kendrick

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siying Wang, Dr.

Role: STUDY_CHAIR

University of Electronic Science and Technology of China

Locations

University of Electronic Science and Technology of China(UESTC)

Sichuan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Keith M Kendrick, Dr.

Role: CONTACT

k.kendrick.uestc@gmail.com

+86-28-61830811

Shuxia Yao, Dr.

Role: CONTACT

yaoshuxia@uestc.edu.cn

+8618111297596

Other Identifiers

UESTC-neuSCAN-92

Identifier Type: -

Identifier Source: org_study_id