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

Overview

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.

Full Title of Study: “Comparison of Direct and Indirect Effects of Intranasal Oxytocin Using Co-administration With a Vasoconstrictor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 18, 2019

Interventions

  • Drug: vasoconstrictor and oxytocin treatment
    • intransal administration of vasoconstrictor and oxytocin
  • Drug: vasoconstrictor’s placebo and oxytocin treatment
    • intransal administration of vasoconstrictor’s placebo and oxytocin
  • Drug: vasoconstrictor and oxytocin’s placebo treatment
    • intransal administration of vasoconstrictor and oxytocin’s placebo

Arms, Groups and Cohorts

  • Experimental: vasoconstrictor + intranasal oxytocin group
    • subjects receive the vasoconstrictor followed by oxytocin
  • Active Comparator: vasoconstrictor’s placebo + intranasal oxytocin group
    • subjects receive the vasoconstrictor’s placebo followed by oxytocin
  • Placebo Comparator: vasoconstrictor + intranasal oxytocin placebo group
    • subjects receive the vasoconstrictor followed by intranasal oxytocin’s placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria

  • history of head injury
  • medical or psychiatric illness.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Electronic Science and Technology of China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Keith Kendrick, Professor – University of Electronic Science and Technology of China
  • Overall Contact(s)
    • Shuxia Yao, +8618111297596, yaoshuxia@uestc.edu.cn

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