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

NCT04134663 | Completed

• 1 other identifier: UESTC-neuSCAN-43
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

vasoconstrictor; oxytocin; EEG; peripheral nervous system response

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• heartrate

  2 hours

• skin conductance

  2 hours

• gastrointestinal activity

  2 hours

Study Arms (3)

vasoconstrictor + intranasal oxytocin group

EXPERIMENTAL

subjects receive the vasoconstrictor followed by oxytocin

Drug: vasoconstrictor and oxytocin treatment

vasoconstrictor's placebo + intranasal oxytocin group

ACTIVE COMPARATOR

subjects receive the vasoconstrictor's placebo followed by oxytocin

Drug: vasoconstrictor's placebo and oxytocin treatment

vasoconstrictor + intranasal oxytocin placebo group

PLACEBO COMPARATOR

subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo

Drug: vasoconstrictor and oxytocin's placebo treatment

Interventions

vasoconstrictor and oxytocin treatment DRUG

intransal administration of vasoconstrictor and oxytocin

vasoconstrictor + intranasal oxytocin group

vasoconstrictor's placebo and oxytocin treatment DRUG

intransal administration of vasoconstrictor's placebo and oxytocin

vasoconstrictor's placebo + intranasal oxytocin group

vasoconstrictor and oxytocin's placebo treatment DRUG

intransal administration of vasoconstrictor and oxytocin's placebo

vasoconstrictor + intranasal oxytocin placebo group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects without past or current psychiatric or neurological disorders

You may not qualify if:

• history of head injury
• medical or psychiatric illness.

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

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

Chengdu, Sichuan, 610054, China

Location

MeSH Terms

Interventions

Vasoconstrictor Agents

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: March 2, 2019
• Primary Completion: June 18, 2021
• Study Completion: July 20, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

CN (1)