NCT03278860

Brief Summary

The main aim of the study is to investigate whether intranasal oxytocin (24IU) can enhance hedonic experience and associated brain-reward reward responses to social touch.

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
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2017

Longer than P75 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

August 28, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

September 6, 2017

Last Update Submit

October 26, 2018

Conditions

Keywords

Oxytocinsocial touch

Outcome Measures

Primary Outcomes (1)

  • Neural indices: fMRI-based measures of interoceptive and reward processing

    fMRI-based measures of social and non-social touch-related brain activity

    45-90 minutes after treatment administration

Secondary Outcomes (3)

  • Behavioral index: pleasantness experience

    45-90 minutes after treatment administration

  • Behavioral index: likability experience

    45-90 minutes after treatment administration

  • Behavioral index: arousal experience

    45-90 minutes after treatment administration

Study Arms (2)

Oxytocin then placebo

EXPERIMENTAL

Participants first received oxytocin (24 IU). After a washout period of 2 weeks, they then received placebo (24 IU).

Drug: intranasal oxytocinDrug: intranasal placebo

Placebo then oxytocin

EXPERIMENTAL

Participants first received placebo (24 IU). After a washout period of 2 weeks, they then received oxytocin (24 IU).

Drug: intranasal oxytocinDrug: intranasal placebo

Interventions

24 IU of oxytocin nasal spray will be applied to each subject.

Oxytocin then placebo

an identical amount of placebo nasal spray will be applied to each subject.

Oxytocin then placebo

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

You may not qualify if:

  • History of brain injury
  • Medical or mental illness

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

RECRUITING

Related Publications (1)

  • Chen Y, Li Q, Zhang Q, Kou J, Zhang Y, Cui H, Wernicke J, Montag C, Becker B, Kendrick KM, Yao S. The Effects of Intranasal Oxytocin on Neural and Behavioral Responses to Social Touch in the Form of Massage. Front Neurosci. 2020 Dec 4;14:589878. doi: 10.3389/fnins.2020.589878. eCollection 2020.

Study Officials

  • Qin Li, MA

    University of Electronic Science and Technology of China

    STUDY CHAIR

Central Study Contacts

Keith M Kendrick, Dr.

CONTACT

Benjamin Becker, Dr.

CONTACT

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

September 6, 2017

First Posted

September 12, 2017

Study Start

August 28, 2017

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations