Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

April 1, 2025 updated by: Benjamin Becker, University of Electronic Science and Technology of China
The main aim of the study is to investigate the modulatory effects of intranasal oxytocin (24IU) on fear in naturalistic social and non-social contexts and the underlying neural mechanisms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to receive either intranasal oxytocin (24IU, n= 30) or placebo (n = 30) nasal spray. 45 minutes after treatment the participants will undergo a naturalistic fear induction paradigm during fMRI. During the paradigm video clips of 25s lengths will be presented showing fear-inducing situations in social and non-social contexts as well as corresponding control video clips. Following each clip subjects are required to rate their level of subjective fear on a rating scale ranging from 1 (no fear) to 9 (highest fear). Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • University of Electronic Science and Technology of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy subjects without past or current psychiatric or neurological disorders
  • Right-handedness
  • Normal or corrected-normal version

Exclusion Criteria:

  • History of head injury
  • Medical or psychiatric illness
  • Hypertension
  • General cardio-vascular alteration or diseases
  • Allergy against medications
  • Visual or motor impairments
  • Claustrophobia
  • Drug addiction
  • Nicotine dependence
  • FMRI contradictions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytoxin group
Drug: intranasal Oxytocin(24IU)
Drug: intranasal Oxytocin(24IU)
Administration of intranasal Oxytocin(24IU)
Placebo Comparator: Placebo group
Drug: intranasal Placebo
Drug: intranasal Placebo
Administration of intranasal Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI)
Time Frame: 45 minutes to 70 minutes after treatment
BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI) in response to four conditions of movie clips (Fear-Social\FS, Fear-Non-social\FNS, Neutral-Social\NS, Neutral-Non-social\NNS). Effects of Oxytocin on the neural basis of fear will be examined by comparing the treatment groups (Oxytocin versus Placebo) with respect to fearful versus non fearful conditions. The investigators expect that Oxytocin will decrease reactivity in emotion reactive brain regions as compared to Placebo.
45 minutes to 70 minutes after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experienced fear during the paradigm as assessed by self-reported ratings
Time Frame: 45 minutes to 70 minutes after treatment
Experienced fear during the paradigm as assessed by self-reported ratings on a 1-9 point Likert-scale ranging from 1 (no fear) to 9 (highest fear). Participants will rate their subjective level of fear following each video clip. Effects of Oxytocin on the level of subjective fear will be examined by comparing the treatment groups (Oxytocin versus Placebo) with respect to the self-reported fear levels. The investigators expect that Oxytocin will decrease the level of subjective fear experience compared to Placebo.
45 minutes to 70 minutes after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Investigators

  • Principal Investigator: Benjamin Becker, Dr., University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UESTC-BAM-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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