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Clinical Trials/NCT04134663
NCT04134663
Completed
Not Applicable

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

University of Electronic Science and Technology of China1 site in 1 country96 target enrollmentMarch 2, 2019

Overview

Phase
Not Applicable
Intervention
vasoconstrictor's placebo and oxytocin treatment
Conditions
Healthy
Sponsor
University of Electronic Science and Technology of China
Enrollment
96
Locations
1
Primary Endpoint
blood oxytocin concentration
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2019
End Date
July 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
University of Electronic Science and Technology of China
Responsible Party
Principal Investigator
Principal Investigator

Keith Kendrick

Professor

University of Electronic Science and Technology of China

Eligibility Criteria

Inclusion Criteria

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria

  • history of head injury
  • medical or psychiatric illness.

Arms & Interventions

vasoconstrictor's placebo + intranasal oxytocin group

subjects receive the vasoconstrictor's placebo followed by oxytocin

Intervention: vasoconstrictor's placebo and oxytocin treatment

vasoconstrictor + intranasal oxytocin group

subjects receive the vasoconstrictor followed by oxytocin

Intervention: vasoconstrictor and oxytocin treatment

vasoconstrictor + intranasal oxytocin placebo group

subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo

Intervention: vasoconstrictor and oxytocin's placebo treatment

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • heartrate(2 hours)
  • gastrointestinal activity(2 hours)
  • skin conductance(2 hours)

Study Sites (1)

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