Comparison of Direct and Indirect Effects of Intranasal Oxytocin Using Co-administration With a Vasoconstrictor
Overview
- Phase
- Not Applicable
- Intervention
- vasoconstrictor's placebo and oxytocin treatment
- Conditions
- Healthy
- Sponsor
- University of Electronic Science and Technology of China
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- blood oxytocin concentration
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Keith Kendrick
Professor
University of Electronic Science and Technology of China
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects without past or current psychiatric or neurological disorders
Exclusion Criteria
- •history of head injury
- •medical or psychiatric illness.
Arms & Interventions
vasoconstrictor's placebo + intranasal oxytocin group
subjects receive the vasoconstrictor's placebo followed by oxytocin
Intervention: vasoconstrictor's placebo and oxytocin treatment
vasoconstrictor + intranasal oxytocin group
subjects receive the vasoconstrictor followed by oxytocin
Intervention: vasoconstrictor and oxytocin treatment
vasoconstrictor + intranasal oxytocin placebo group
subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo
Intervention: vasoconstrictor and oxytocin's placebo treatment
Outcomes
Primary Outcomes
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 Outcomes
- heartrate(2 hours)
- gastrointestinal activity(2 hours)
- skin conductance(2 hours)