Comparison of Intranasal Oxytocin Effects Using Co-administration With a Vasoconstrictor

NCT ID: NCT04134663

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-02

Study Completion Date

2021-07-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vasoconstrictor + intranasal oxytocin group

subjects receive the vasoconstrictor followed by oxytocin

Group Type EXPERIMENTAL

vasoconstrictor and oxytocin treatment

Intervention Type DRUG

intransal administration of vasoconstrictor and oxytocin

vasoconstrictor's placebo + intranasal oxytocin group

subjects receive the vasoconstrictor's placebo followed by oxytocin

Group Type ACTIVE_COMPARATOR

vasoconstrictor's placebo and oxytocin treatment

Intervention Type DRUG

intransal administration of vasoconstrictor's placebo and oxytocin

vasoconstrictor + intranasal oxytocin placebo group

subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo

Group Type PLACEBO_COMPARATOR

vasoconstrictor and oxytocin's placebo treatment

Intervention Type DRUG

intransal administration of vasoconstrictor and oxytocin's placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vasoconstrictor and oxytocin treatment

intransal administration of vasoconstrictor and oxytocin

Intervention Type DRUG

vasoconstrictor's placebo and oxytocin treatment

intransal administration of vasoconstrictor's placebo and oxytocin

Intervention Type DRUG

vasoconstrictor and oxytocin's placebo treatment

intransal administration of vasoconstrictor and oxytocin's placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria

* history of head injury
* medical or psychiatric illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Keith Kendrick

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

school of life science and technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UESTC-neuSCAN-43

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

S-ketamin Premedication in Pediatric EENT Surgery
NCT04757675 COMPLETED EARLY_PHASE1