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

University of Electronic Science and Technology of China

Status: Completed

Conditions: Healthy

Treatments: Drug: vasoconstrictor and oxytocin treatment; Drug: vasoconstrictor's placebo and oxytocin treatment; Drug: vasoconstrictor and oxytocin's placebo treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04134663

UESTC-neuSCAN-43

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects without past or current psychiatric or neurological disorders

Exclusion criteria

• history of head injury
• medical or psychiatric illness.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups, including a placebo group

vasoconstrictor + intranasal oxytocin group

Experimental group

Description:

subjects receive the vasoconstrictor followed by oxytocin

Treatment:

Drug: vasoconstrictor and oxytocin treatment

vasoconstrictor's placebo + intranasal oxytocin group

Active Comparator group

Description:

subjects receive the vasoconstrictor's placebo followed by oxytocin

Treatment:

Drug: vasoconstrictor's placebo and oxytocin treatment

vasoconstrictor + intranasal oxytocin placebo group

Placebo Comparator group

Description:

subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo

Treatment:

Drug: vasoconstrictor and oxytocin's placebo treatment