NCT05265806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

February 20, 2022

Last Update Submit

May 10, 2023

Conditions

Healthy

Keywords

OxytocinSocial touchfNIRS

Outcome Measures

Primary Outcomes (2)

  • Neural index: fNIRS based measures of touch processing

    fNIRS-based indices of neural processing of social touch after the oxytocin and placebo administration in response to each experimental condition.

    35-90 minutes after treatment administration

  • Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch

    Ratings of perceived pleasantness, arousal, intensity and the willing to pay for the applied caress-like touch and massage after the oxytocin and placebo administration.

    50-90 minutes after treatment administration

Secondary Outcomes (5)

  • Plasma oxytocin concentration

    Basal concentration before treatment and altered level during 30-90 minutes after treatment administration

  • Electrophysiological index: skin conductance responses (SCR)

    35-90 minutes after treatment administration

  • Electrophysiological index: heart rate variability (HRV)

    35-90 minutes after treatment administration

  • Questionnaire scores of autistic traits

    Before the experiment

  • Gender difference in the neural and behavioral index

    35-90 minutes after treatment administration

Study Arms (3)

Intranasal oxytocin

EXPERIMENTAL

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

Drug: Intranasal oxytocin

Oral oxytocin

EXPERIMENTAL

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

Drug: Oral oxytocin

Placebo

PLACEBO COMPARATOR

Participants will be randomly assigned to the administration of placebo.

Drug: Placebo

Interventions

Intranasal oxytocinDRUG

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

Also known as: Oxytocin intranasal spray
Intranasal oxytocin
Oral oxytocinDRUG

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

Also known as: Oxytocin lingual spray
Oral oxytocin
PlaceboDRUG

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.

Also known as: PLC
Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.

You may not qualify if:

  • Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, 611731, China

Location

Related Publications (2)

  • 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.

    PMID: 37219072DERIVED

  • 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.

    PMID: 37171081DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Qin Li, Dr.

    University of Electronic Science and Technology of China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized placebo-controlled double-blind mixed experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
: Professor

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 4, 2022

Study Start

September 1, 2021

Primary Completion

March 1, 2022

Study Completion

May 25, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

CN(1)