The Role of Oxytocin and Arginine Vasopressin in Human Placebo Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 1
研究概览
简要总结
Background:
- Oxytocin, a substance produced mostly in the brain, plays a role in influencing social interactions and reactions to stress, and may be related to pain. Arginine vasopressin, a hormone that regulates water, sugar, and salt in the blood, influences hostile behaviors and reactions to stress, and may also be related to pain. Researchers are interested in investigating both substances and their relationship to pain in healthy volunteers.
Objectives:
- To evaluate the effects of oxytocin and arginine vasopressin on pain in healthy volunteers.
Eligibility:
- Healthy volunteers between 18 and 55 years of age.
Design:
- This study involves two 2-hour testing sessions held 1 day apart. Each session includes the administration of oxytocin, arginine vasopressin, or placebo (a nonactive substance), or no drug. The drugs and the placebo will be given by a nasal spray.
- At the first visit, participants will provide blood and saliva samples to measure hormone levels, and will be asked to fill out questionnaires about some psychological factors such as anxiety and empathy. Participants will then have an assessment of their sensitivity to pain, consisting of a brief electrical stimulation that lasts less than 1 second. After the pain assessment, participants will receive oxytocin, arginine vasopressin, placebo, or no drug at all, and will be monitored to provide baseline information. Participants will then have another pain sensitivity test and will complete the questionnaires again, and provide another saliva sample.
- At the second visit, participants will provide another saliva sample; receive oxytocin, arginine vasopressin, placebo, or no drug at all; and have tests of pain sensitivity and a pain-relieving procedure. During the pain-relieving procedure, participants will receive brief, moderately painful electrical shocks on the back of the nondominant hand and a low-level electrical stimulation on the middle finger that counteracts or reduces the pain from the shocks. Participants will rate their pain perception at the end of each stimulation by using a visual scale ranging from 0 (no pain) to 10 (maximum imaginable pain). The experiment ends with a final saliva collection and completion of the psychological questionnaires.
详细描述
Objective:
It is well known that social and contextual cues and the whole atmosphere around the patient, such as words, attitudes, and providers behaviors, all contribute to evoke placebo responses. Moreover, an extensive literature investigating prosocial behaviors (e.g. ability to share another s feelings, imitation, mimicry) suggests that social modeling is critical in developing learning processes across species, including social influences on psychophysical aspects of pain. Only recently, it has been demonstrated that observing the beneficial effects in a demonstrator induces substantial placebo analgesic responses which are positively correlated with empathy. A crucial role in social behaviors is played by oxytocin (OXT) and arginine vasopressin (AVP), two neuropeptides, produced mostly in the hypothalamus and acting on certain brain regions whose function is associated with emotion perception (amygdale and nucleus accumbens), eye-gaze, trust and processing of positive and negative social cues. Since beliefs, trust and contextual cues are important elements of the clinicianpatient relationship and socially-induced placebo effects, it is reasonable to hypothesize that OXT and AVP may be one of the endogenous substances that trigger contextual and interpersonal placebo responses. By viewing interpersonal healing as a central causal process (or a set of related causal processes) within the domain of pain modulation, it is possible to probe the potential role for OXT and AVP in the modulation of a placebo response. In pursuit of this goal, we use a neuropharmacological intervention with OXT and AVP agonists in combination with a behavioral, brain imaging and genetic approach.
Study population:
Healthy men and women participants aging from 18 to 55 years.
Design:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供