NCT05899517

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

June 22, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

May 5, 2023

Last Update Submit

June 1, 2023

Conditions

Keywords

OxytocinAffective touchSelf versus other distinctionfMRI

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • Questionnaire scores for autistic traits using the Autism Spectrum Quotient (ASQ)

    Before the experiment

  • Questionnaire scores for attitudes towards touch using the Social Touch Questionnaire

    Before the experiment

  • Questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)

    Before the experiment

  • Behavioral associations with autistic traits using the Autism Spectrum Quotient (ASQ)

    Before the experiment

  • Neural associations with autistic traits using the Autism Spectrum Quotient (ASQ)

    Before the experiment

  • +9 more secondary outcomes

Study Arms (2)

Oral oxytocin then placebo

EXPERIMENTAL

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)Drug: oral lollipop with placebo

Oral placebo then oxytocin

EXPERIMENTAL

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)Drug: oral lollipop with placebo

Interventions

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.

Also known as: oral oxytocin
Oral oxytocin then placeboOral placebo then oxytocin

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.

Also known as: oral placebo
Oral oxytocin then placeboOral placebo then oxytocin

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
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)

Sichuan, China

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Siying Wang, Dr.

    University of Electronic Science and Technology of China

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 5, 2023

First Posted

June 12, 2023

Study Start

June 22, 2022

Primary Completion

July 30, 2023

Study Completion

December 1, 2023

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations