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NCT Number: NCT04134663

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

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Chengdu, Sichuan, 610054, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion criteria

  • history of head injury
  • medical or psychiatric illness.

Treatment and study plan

vasoconstrictor and oxytocin treatment

Drug

intransal administration of vasoconstrictor and oxytocin

vasoconstrictor's placebo and oxytocin treatment

Drug

intransal administration of vasoconstrictor's placebo and oxytocin

vasoconstrictor and oxytocin's placebo treatment

Drug

intransal administration of vasoconstrictor and oxytocin's placebo

Primary outcomes

  1. blood oxytocin concentration

    Time frame: 2 hours

    blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament

  2. resting EEG time-frequency

    Time frame: 2 hours

    resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament

Secondary outcomes

  1. heartrate

    Time frame: 2 hours

    heartrate (and heartrate variability) changes following vasoconstrictor/placebo and oxytocin/placebo treament

  2. skin conductance

    Time frame: 2 hours

    skin conductance level (measured by skin conductance response) changes following vasoconstrictor/placebo and oxytocin/placebo treament

  3. gastrointestinal activity

    Time frame: 2 hours

    gastrointestinal activity (measured by electrogastrogram) changes following vasoconstrictor/placebo and oxytocin/placebo treament

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2019
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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