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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: vasoconstrictor's placebo and oxytocin treatment; Drug: vasoconstrictor and oxytocin's placebo treatment; Drug: vasoconstrictor and oxytocin treatment

• Registration Number: NCT04134663
• Lead Sponsor: University of Electronic Science and Technology of China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-02
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-22
• Primary Completion: 2021-06-18
• Study Completion: 2021-07-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

Inclusion Criteria

• Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria

• history of head injury
• medical or psychiatric illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vasoconstrictor's placebo + intranasal oxytocin group	vasoconstrictor's placebo and oxytocin treatment	subjects receive the vasoconstrictor's placebo followed by oxytocin
vasoconstrictor + intranasal oxytocin placebo group	vasoconstrictor and oxytocin's placebo treatment	subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo
vasoconstrictor + intranasal oxytocin group	vasoconstrictor and oxytocin treatment	subjects receive the vasoconstrictor followed by oxytocin

Primary Outcome Measures

Name	Time	Method
blood oxytocin concentration	2 hours	blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament
resting EEG time-frequency	2 hours	resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament

Secondary Outcome Measures

Name	Time	Method
heartrate	2 hours	heartrate (and heartrate variability) changes following vasoconstrictor/placebo and oxytocin/placebo treament
gastrointestinal activity	2 hours	gastrointestinal activity (measured by electrogastrogram) changes following vasoconstrictor/placebo and oxytocin/placebo treament
skin conductance	2 hours	skin conductance level (measured by skin conductance response) changes following vasoconstrictor/placebo and oxytocin/placebo treament

Trial Locations

Locations (1)

school of life science and technology, University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China