HealthyNCT04134663
Comparison of Intranasal Oxytocin Effects Using Co-administration With a Vasoconstrictor
A study testing vasoconstrictor and oxytocin treatment in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
This study aims to dissociate direct from indirectly mediated effects of intranasal oxytocin administration by using treatment with or without prior intranasal administration of a vasoconstrictor to reduce peripheral increases in peptide concentrations. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- vasoconstrictor and oxytocin treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2019to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
Who cannot join
- history of head injury
- medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
China1 site
school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
About this study
Official title: Comparison of Direct and Indirect Effects of Intranasal Oxytocin Using Co-administration With a Vasoconstrictor
This study aims to dissociate direct from indirectly mediated effects of intranasal oxytocin administration by using treatment with or without prior intranasal administration of a vasoconstrictor to reduce peripheral increases in peptide concentrations. Primary outcomes of the randomized placebo-controlled double-blind experiment are blood oxytocin concentration and oxytocin-associated responses in central and peripheral systems.
Intranasal application of the neuropeptide oxytocin has been reported to produce a number of neural, physiological and behavior effects which may be of potential therapeutic relevance, but it is unclear the extent to which they are mediated directly via the peptide entering the brain or indirectly as a result of increased peripheral concentrations. In the current placebo-controlled, double blind experiment on healthy adult male subjects the investigators will measure the effects of a single dose of intranasal oxytocin (24IU) on brain activity (using electroencephaolography - EEG) as well as on cardiac (heart-rate and heart-rate variablility) and gastric (electrogastrogram - EGG) activity and physiological arousal (skin conductance response - SCR). The pattern of functional effects observed will be compared with subjects receiving intranasal pretreatment with a vasoconstrictor prior to oxytocin in order to reduce the amount of oxytocin entering the peripheral circulation. The investigators hypothesize that prior administration of the vasoconstrictor will greatly reduce blood oxytocin concentrations following intranasal oxytocin treatment. Where neural/physiological effects are also affected, this will indicate an indirectly mediated action of intranasally administered oxytocin whereas if they are not this will indicate a directly mediated action.
- Conditions
- Healthy
- Being tested
- vasoconstrictor and oxytocin treatment, vasoconstrictor's placebo and oxytocin treatment, vasoconstrictor and oxytocin's placebo treatment
- Keywords
- vasoconstrictor, oxytocin, EEG, peripheral nervous system response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasoconstrictor and oxytocin treatmentDrug
intransal administration of vasoconstrictor and oxytocin
vasoconstrictor's placebo and oxytocin treatmentDrug
intransal administration of vasoconstrictor's placebo and oxytocin
vasoconstrictor and oxytocin's placebo treatmentDrug
intransal administration of vasoconstrictor and oxytocin's placebo
| Study group | Role | What they receive |
|---|---|---|
| vasoconstrictor + intranasal oxytocin group | Experimental | subjects receive the vasoconstrictor followed by oxytocin Receives: Drug: vasoconstrictor and oxytocin treatment |
| vasoconstrictor's placebo + intranasal oxytocin group | Active comparator | subjects receive the vasoconstrictor's placebo followed by oxytocin Receives: Drug: vasoconstrictor's placebo and oxytocin treatment |
| vasoconstrictor + intranasal oxytocin placebo group | Placebo comparator | subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo Receives: Drug: vasoconstrictor and oxytocin's placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood oxytocin concentration
blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament
Measured: 2 hours
resting EEG time-frequency
resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament
Measured: 2 hours
Secondary outcomes (3)
heartrate
heartrate (and heartrate variability) changes following vasoconstrictor/placebo and oxytocin/placebo treament
Measured: 2 hours
skin conductance
skin conductance level (measured by skin conductance response) changes following vasoconstrictor/placebo and oxytocin/placebo treament
Measured: 2 hours
gastrointestinal activity
gastrointestinal activity (measured by electrogastrogram) changes following vasoconstrictor/placebo and oxytocin/placebo treament
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start2 Mar 2019
- Primary completion18 Jun 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 96 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134663
- Sponsor's protocol ID
- UESTC-neuSCAN-43
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2019
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Direct and Indirect Effects of Intranasal Oxytocin Using Co-administration With a Vasoconstrictor
- ClinicalTrials.gov ID
- NCT04134663
- Acronym / sponsor ID
- UESTC-neuSCAN-43
- Conditions
- Healthy
- Keywords
- vasoconstrictor, oxytocin, EEG, peripheral nervous system response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to dissociate direct from indirectly mediated effects of intranasal oxytocin administration by using treatment with or without prior intranasal administration of a vasoconstrictor to reduce peripheral increases in peptide concentrations. Primary outcomes of the randomized placebo-controlled double-blind experiment are blood oxytocin concentration and oxytocin-associated responses in central and peripheral systems.
Intranasal application of the neuropeptide oxytocin has been reported to produce a number of neural, physiological and behavior effects which may be of potential therapeutic relevance, but it is unclear the extent to which they are mediated directly via the peptide entering the brain or indirectly as a result of increased peripheral concentrations. In the current placebo-controlled, double blind experiment on healthy adult male subjects the investigators will measure the effects of a single dose of intranasal oxytocin (24IU) on brain activity (using electroencephaolography - EEG) as well as on cardiac (heart-rate and heart-rate variablility) and gastric (electrogastrogram - EGG) activity and physiological arousal (skin conductance response - SCR). The pattern of functional effects observed will be compared with subjects receiving intranasal pretreatment with a vasoconstrictor prior to oxytocin in order to reduce the amount of oxytocin entering the peripheral circulation. The investigators hypothesize that prior administration of the vasoconstrictor will greatly reduce blood oxytocin concentrations following intranasal oxytocin treatment. Where neural/physiological effects are also affected, this will indicate an indirectly mediated action of intranasally administered oxytocin whereas if they are not this will indicate a directly mediated action.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vasoconstrictor + intranasal oxytocin group | Experimental | Drug: vasoconstrictor and oxytocin treatmentsubjects receive the vasoconstrictor followed by oxytocin |
| vasoconstrictor's placebo + intranasal oxytocin group | Active comparator | Drug: vasoconstrictor's placebo and oxytocin treatmentsubjects receive the vasoconstrictor's placebo followed by oxytocin |
| vasoconstrictor + intranasal oxytocin placebo group | Placebo comparator | Drug: vasoconstrictor and oxytocin's placebo treatmentsubjects receive the vasoconstrictor followed by intranasal oxytocin's placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (2 listed)
- history of head injury
- medical or psychiatric illness.
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 |
|---|---|---|
| vasoconstrictor and oxytocin treatmentintransal administration of vasoconstrictor and oxytocin | Drug | vasoconstrictor + intranasal oxytocin group |
| vasoconstrictor's placebo and oxytocin treatmentintransal administration of vasoconstrictor's placebo and oxytocin | Drug | vasoconstrictor's placebo + intranasal oxytocin group |
| vasoconstrictor and oxytocin's placebo treatmentintransal administration of vasoconstrictor and oxytocin's placebo | Drug | vasoconstrictor + intranasal oxytocin placebo group |
Primary outcome
blood oxytocin concentration
Time frame: 2 hours
blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament
resting EEG time-frequency
Time frame: 2 hours
resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament
3 secondary outcomes
heartrate
Time frame: 2 hours
skin conductance
Time frame: 2 hours
gastrointestinal activity
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vasoconstrictor and oxytocin treatment in people with Healthy, 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 2 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 11 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blood oxytocin concentration (time frame: 2 hours). 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 11 Feb 2022.