The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers Using a Double-blind Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Placebo analgesic responses
研究概览
简要总结
Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.
详细描述
Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.
The rationale to study the effects of oxytocin on placebo analgesia is based on previous studies showing that oxytocin fosters processes such as empathy, trust and social learning, which are key elements of the patient-physician relationship that is pivotal to placebo responses. In this experimental mechanisms study we used oxytocin as a tool to modulate these factors.
Placebo analgesia is induced verbal instruction. Therefore two identically looking placebo ointments were applied to two sites of the participants' volar forearm. The ointments were introduced as a local anesthetic that could reduce or even abolish pain (placebo) and a control cream (control), respectively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers, male and female
- •being German-speaking
- •Agreeing to participate, verified by completion of informed consent
排除标准
- •acute or chronic pain condition
- •use of any concomitant medication except contraceptives
- •currently pregnant (verified by urine pregnancy test) or lactating
- •major mental disorder
- •Inability to comply with the study procedures
- •abnormal pain sensitivity as indicated by pain threshold
- •alcohol intake within last 24 hours
研究组 & 干预措施
oxytocin
application of intranasal oxytocin 40IE
干预措施: Oxytocin (Drug)
placebo
application of intranasal saline
Both sprays (saline/oxytocin) are delivered in identical containers manufactured by the University pharmacy to assure blinding.
干预措施: placebo (Other)
结局指标
主要结局
Placebo analgesic responses
时间窗: ~ 45 min after appliction of oxytocin or saline
In this study the placebo analgesic response is defined as the difference in pain rating (visual analogue scale \[0-100\]) to thermal painful stimulation on the forearm on the placebo site compared to a control site.
次要结局
- pain rating on the control site(~45 min after application)
研究者
Ulrike Bingel
PD Dr. Ulrike Bingel, attending of neurology, research group leader
Universitätsklinikum Hamburg-Eppendorf