The Effects of Oxytocin Treatment on Social Touch

NCT ID: NCT05265806

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-05-25

Brief Summary

The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administration on the affective processing of touch manipulated differently in gentle caress-like stroke vs. social massage with a moderate pressure.

Detailed Description

A randomized double-blind placebo-controlled mixed experimental design with three arms (intranasal oxytocin administration vs. oral oxytocin administration vs. placebo administration, each with 60 subjects) will be employed in the current study. 35 minutes after treatment subjects will be applied two different types of pleasant touch (social massage vs. caress-like stroking) to their calf. After each applied touch stimulation session, the subjects will be asked to rate their subjective experience of the touch including the perceived pleasantness, arousal, intensity and payment. The neural basis of touch processing will be measured via simultaneously acquired fNIRS together with skin conductance responses and the electrocardiogram recording. Blood samples will be taken before and after the treatment as well as after each run session to measure plasma oxytocin levels to explore the associations with primary outcome measure (the behavioral and neural measures of touch processing). Mixed-measure analysis of variance (ANOVA) with treatment as between-subject factor and condition as within-subject factor will be used to investigate oxytocin effects on social touch processing.

To control potential confounding effects across groups, 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 sensitivity to reward: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), the Cheek and Buss Shyness Scale (CBSS), the Adult Attachment Scale (AAS), the Childhood Trauma Questionnaire (CTQ), social touch questionnaire (STQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Sensory Over-Responsivity (SensOR) Scales and the Interpersonal Reactivity Index (C-IRI). And associations between questionnaire scores (especially the ASQ and STQ scores) with primary outcome measure will be explored to investigate modulatory effects of autistic traits. 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 each type of touch condition to further measure the modulatory effects of stroking touch and massage on mood.

Conditions

Healthy

Study Design

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

Study Groups

Intranasal oxytocin

Participants will be randomly assigned to the administration of oxytocin intranasal spray (24 IU).

Group Type: EXPERIMENTAL

Intranasal oxytocin

Intervention Type: DRUG

Each subject will be assigned to administration of oxytocin intranasal spray (24 IU).

Oral oxytocin

Participants will be randomly assigned to the administration of oxytocin lingual spray (24 IU).

Group Type: EXPERIMENTAL

Oral oxytocin

Intervention Type: DRUG

Each subject will be assigned to administration of oxytocin lingual spray (24 IU).

Placebo

Participants will be randomly assigned to the administration of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

An identical amount of intranasal administration of placebo (identical ingredients except the peptide - i.e. glycerine and sodium chloride) will be assigned to each subject.

Interventions

Intranasal oxytocin

Each subject will be assigned to administration of oxytocin intranasal spray (24 IU).

Intervention Type: DRUG

Oral oxytocin

Each subject will be assigned to administration of oxytocin lingual spray (24 IU).

Intervention Type: DRUG

Placebo

An identical amount of intranasal administration of placebo (identical ingredients except the peptide - i.e. glycerine and sodium chloride) will be assigned to each subject.

Intervention Type: DRUG

Other Intervention Names

Oxytocin intranasal spray; Oxytocin lingual spray; PLC

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: ALL
• 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

Qin Li, Dr.

Role: STUDY_CHAIR

University of Electronic Science and Technology of China

Locations

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, China

Countries

China

References

Yamagata T, Ogiwara I, Tatsukawa T, Suzuki T, Otsuka Y, Imaeda N, Mazaki E, Inoue I, Tokonami N, Hibi Y, Itohara S, Yamakawa K. Scn1a-GFP transgenic mouse revealed Nav1.1 expression in neocortical pyramidal tract projection neurons. Elife. 2023 May 23;12:e87495. doi: 10.7554/eLife.87495.

Reference Type: DERIVED

PMID: 37219072 (View on PubMed)

Chen Y, Zou H, Hou X, Lan C, Wang J, Qing Y, Chen W, Yao S, Kendrick KM. Oxytocin administration enhances pleasantness and neural responses to gentle stroking but not moderate pressure social touch by increasing peripheral concentrations. Elife. 2023 May 12;12:e85847. doi: 10.7554/eLife.85847.

Reference Type: DERIVED

PMID: 37171081 (View on PubMed)

Other Identifiers

UESTC-neuSCAN-79

Identifier Type: -

Identifier Source: org_study_id