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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vasoconstrictor + intranasal oxytocin group | Experimental | subjects receive the vasoconstrictor followed by oxytocin |
|
| vasoconstrictor's placebo + intranasal oxytocin group | Active Comparator | subjects receive the vasoconstrictor's placebo followed by oxytocin |
|
| vasoconstrictor + intranasal oxytocin placebo group | Placebo Comparator | subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vasoconstrictor and oxytocin treatment | Drug | intransal administration of vasoconstrictor and oxytocin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| school of life science and technology, University of Electronic Science and Technology of China | Chengdu | Sichuan | 610054 | China |
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| vasoconstrictor's placebo and oxytocin treatment | Drug | intransal administration of vasoconstrictor's placebo and oxytocin |
|
| vasoconstrictor and oxytocin's placebo treatment | Drug | intransal administration of vasoconstrictor and oxytocin's placebo |
|
| 2 hours |
| gastrointestinal activity | gastrointestinal activity (measured by electrogastrogram) changes following vasoconstrictor/placebo and oxytocin/placebo treament | 2 hours |
| ID | Term |
|---|---|
| D014662 | Vasoconstrictor Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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