Comparison of Direct and Indirect Effects of Intranasal Oxytocin Using Co-administration With a Vasoconstrictor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- blood oxytocin concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects without past or current psychiatric or neurological disorders
排除标准
- •history of head injury
- •medical or psychiatric illness.
研究组 & 干预措施
vasoconstrictor's placebo + intranasal oxytocin group
subjects receive the vasoconstrictor's placebo followed by oxytocin
干预措施: vasoconstrictor's placebo and oxytocin treatment (Drug)
vasoconstrictor + intranasal oxytocin group
subjects receive the vasoconstrictor followed by oxytocin
干预措施: vasoconstrictor and oxytocin treatment (Drug)
vasoconstrictor + intranasal oxytocin placebo group
subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo
干预措施: vasoconstrictor and oxytocin's placebo treatment (Drug)
结局指标
主要结局
blood oxytocin concentration
时间窗: 2 hours
blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament
resting EEG time-frequency
时间窗: 2 hours
resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament
次要结局
- heartrate(2 hours)
- gastrointestinal activity(2 hours)
- skin conductance(2 hours)
研究者
Keith Kendrick
Professor
University of Electronic Science and Technology of China
