InteroceptionNCT03074409
The Modulatory Effect of Oxytocin on Interoception
A study testing oxytocin in people with Interoception, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Interoception
- What is being tested?
- oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2017to 12 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.
Read the 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.
- Conditions
- Interoception
- Being tested
- oxytocin, placebo
- Keywords
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
self-administration of oxytocin (nasal spray)
placeboDrug
self-administration of placebo (nasal spray)
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | intranasal administration of oxytocin Receives: Drug: oxytocin |
| placebo | Placebo comparator | intranasal administration of the same ingredient except oxytocin Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 minutes after oxytocin/placebo treatment
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).
Measured: 45 minutes after oxytocin/placebo treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start2 Mar 2017
- Primary completion6 Sep 2017
- Study completion12 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InteroceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Keith Kendrick, PhD, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074409
- Sponsor's protocol ID
- UESTC-neuSCAN-34
- Status last verified
- Sep 2019
- First submitted
- 3 Mar 2017
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulatory Effect of Oxytocin on Interoception
- ClinicalTrials.gov ID
- NCT03074409
- Acronym / sponsor ID
- UESTC-neuSCAN-34
- Conditions
- Interoception
- Keywords
- Oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: oxytocinintranasal administration of oxytocin |
| placebo | Placebo comparator | Drug: placebointranasal administration of the same ingredient except oxytocin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocinself-administration of oxytocin (nasal spray) | Drug | oxytocin |
| placeboself-administration of placebo (nasal spray) | Drug | placebo |
Primary outcome
Heartbeat Detection (Interoception) Accuracy
Time frame: 45 minutes after oxytocin/placebo treatment
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.
Interoceptive Network Activity
Time frame: 45 minutes after oxytocin/placebo treatment
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Kendrick, PhD principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxytocin in people with Interoception, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heartbeat Detection (Interoception) Accuracy (time frame: 45 minutes after oxytocin/placebo treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.