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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04134663
Enrollment
96
Registered
2019-10-22
Start date
2019-03-02
Completion date
2021-07-20
Last updated
2022-02-11

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

Conditions

Healthy

Keywords

vasoconstrictor, oxytocin, EEG, peripheral nervous system response

Brief 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. 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.

Interventions

DRUGvasoconstrictor and oxytocin treatment

intransal administration of vasoconstrictor and oxytocin

DRUGvasoconstrictor's placebo and oxytocin treatment

intransal administration of vasoconstrictor's placebo and oxytocin

DRUGvasoconstrictor and oxytocin's placebo treatment

intransal administration of vasoconstrictor and oxytocin's placebo

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 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion criteria

* history of head injury * medical or psychiatric illness.

Design outcomes

Primary

MeasureTime frameDescription
blood oxytocin concentration2 hoursblood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament
resting EEG time-frequency2 hoursresting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament

Secondary

MeasureTime frameDescription
heartrate2 hoursheartrate (and heartrate variability) changes following vasoconstrictor/placebo and oxytocin/placebo treament
skin conductance2 hoursskin conductance level (measured by skin conductance response) changes following vasoconstrictor/placebo and oxytocin/placebo treament
gastrointestinal activity2 hoursgastrointestinal activity (measured by electrogastrogram) changes following vasoconstrictor/placebo and oxytocin/placebo treament

Countries

China

Outcome results

None listed

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