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

Comparison of Direct and Indirect Effects of Intranasal Oxytocin 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: vasoconstrictor and oxytocin treatment; Drug: vasoconstrictor's placebo and oxytocin treatment; Drug: vasoconstrictor and oxytocin's placebo treatment

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610054
      • School of Life Science and Technology, University of Electronic Science and Technology of China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

• history of head injury
• medical or psychiatric illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vasoconstrictor + intranasal oxytocin group; subjects receive the vasoconstrictor followed by oxytocin	Drug: vasoconstrictor and oxytocin treatment; intransal administration of vasoconstrictor and oxytocin
Active Comparator: vasoconstrictor's placebo + intranasal oxytocin group; subjects receive the vasoconstrictor's placebo followed by oxytocin	Drug: vasoconstrictor's placebo and oxytocin treatment; intransal administration of vasoconstrictor's placebo and oxytocin
Placebo Comparator: vasoconstrictor + intranasal oxytocin placebo group; subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo	Drug: vasoconstrictor and oxytocin's placebo treatment; intransal administration of vasoconstrictor and oxytocin's placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood oxytocin concentration	blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament	2 hours
resting EEG time-frequency	resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament	2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2019
• Primary Completion (Actual): June 18, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: oxytocin; EEG; vasoconstrictor; peripheral nervous system response
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Vasoconstrictor Agents
• Other Study ID Numbers: UESTC-neuSCAN-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No