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The Modulatory Effect of Oxytocin on Interoception

The Modulatory Effect of Oxytocin on Interoception

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03074409
Enrollment
83
Registered
2017-03-08
Start date
2017-03-02
Completion date
2017-09-12
Last updated
2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interoception

Keywords

Oxytocin

Brief summary

This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.

Detailed description

The present study will use a double-blind, between-subject, placebo-controlled design to investigate the modulatory effect of oxytocin on interoception and whether this effect will vary as a function of emotional valence. In Experiment 1, subjects will perform a heartbeat detection task and the group differences between oxytocin and placebo groups of the interoceptive accuracy and neural activity in the core interoceptive network will be investigated. In Experiment 2, subjects will be asked to watch emotional faces while perform the heartbeat detection task. Investigators will examine whether oxytocin's effects on interoception will be varied as a function of different emotional valence.

Interventions

DRUGoxytocin

self-administration of oxytocin (nasal spray)

DRUGplacebo

self-administration of placebo (nasal spray)

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects

Exclusion criteria

* Subjects reported having any neurological problems, psychiatric illness or drug or alcohol abuse and none were currently taking any form of medication and had not drunk any caffeine-containing beverages on the day of the experiment.

Design outcomes

Primary

MeasureTime frameDescription
Heartbeat Detection (Interoception) Accuracy45 minutes after oxytocin/placebo treatmentheartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (\|recorded heartbeats - counted heartbeats\|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task.
Interoceptive Network Activity45 minutes after oxytocin/placebo treatmentinteroceptive network (including anterior insula and dorsal cingulate cortex) activity as measured by the functional MRI technique in the heartbeat detection task. In the heartbeat detection task participants were instructed to make a keypress each time they felt their heartbeat. The interoceptive network activity was indicated by the percentage of BOLD signal change. The value of the percentage of BOLD signal change indicates the level of a certain brain region activated (the involvement of a brain region in a specific cognitive process).

Countries

China

Participant flow

Participants by arm

ArmCount
Oxytocin
intranasal administration of oxytocin oxytocin: self-administration of oxytocin (nasal spray)
41
Placebo
intranasal administration of the same ingredient except oxytocin placebo: self-administration of placebo (nasal spray)
42
Total83

Baseline characteristics

CharacteristicPlaceboTotalOxytocin
Age, Continuous21.5 years
STANDARD_DEVIATION 2.4
21.35 years
STANDARD_DEVIATION 4.45
21.2 years
STANDARD_DEVIATION 2.5
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
China
42 Participants83 Participants41 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
42 Participants83 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 42
other
Total, other adverse events
0 / 410 / 42
serious
Total, serious adverse events
0 / 410 / 42

Outcome results

Primary

Heartbeat Detection (Interoception) Accuracy

heartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (\|recorded heartbeats - counted heartbeats\|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task.

Time frame: 45 minutes after oxytocin/placebo treatment

Population: 83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects).

ArmMeasureValue (MEAN)Dispersion
OxytocinHeartbeat Detection (Interoception) Accuracy0.637 ratio of correct heartbeat countingStandard Error 0.035
PlaceboHeartbeat Detection (Interoception) Accuracy0.735 ratio of correct heartbeat countingStandard Error 0.034
Primary

Interoceptive Network Activity

interoceptive network (including anterior insula and dorsal cingulate cortex) activity as measured by the functional MRI technique in the heartbeat detection task. In the heartbeat detection task participants were instructed to make a keypress each time they felt their heartbeat. The interoceptive network activity was indicated by the percentage of BOLD signal change. The value of the percentage of BOLD signal change indicates the level of a certain brain region activated (the involvement of a brain region in a specific cognitive process).

Time frame: 45 minutes after oxytocin/placebo treatment

Population: 83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects).

ArmMeasureValue (MEAN)Dispersion
OxytocinInteroceptive Network Activity0.548 percentage of BOLD signal changeStandard Error 0.095
PlaceboInteroceptive Network Activity0.091 percentage of BOLD signal changeStandard Error 0.092

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026