school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054, China
NCT Number: NCT04134663
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.
Looking for future studies?
Notify Me18 year–30 year
Male
Interventional
Not applicable
Chengdu, Sichuan, 610054, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intransal administration of vasoconstrictor and oxytocin
intransal administration of vasoconstrictor's placebo and oxytocin
intransal administration of vasoconstrictor and oxytocin's placebo
Time frame: 2 hours
blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament
Time frame: 2 hours
resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament
Time frame: 2 hours
heartrate (and heartrate variability) changes following vasoconstrictor/placebo and oxytocin/placebo treament
Time frame: 2 hours
skin conductance level (measured by skin conductance response) changes following vasoconstrictor/placebo and oxytocin/placebo treament
Time frame: 2 hours
gastrointestinal activity (measured by electrogastrogram) changes following vasoconstrictor/placebo and oxytocin/placebo treament
University of Electronic Science and Technology of China
Other
Comparison of Direct and Indirect Effects of Intranasal Oxytocin Using Co-administration With a Vasoconstrictor
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.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details