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临床试验/NCT00200876
NCT00200876已完成不适用

Neurochemical Mediation of Placebo Responses in Humans

University of Michigan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Placebo-induced activation of brain opioid neurotransmission

研究概览

简要总结

This study will use brain imaging technology to examine chemical systems in the brain that suppress pain and stress when an individual has an expectation of pain relief.

详细描述

Evidence suggests that the expectation of pain relief, even if a person receives only a placebo, can provide actual therapeutic benefits. The µ-opioid receptor system, located in the brain, is activated during anticipation of pain relief; this activation suppresses stress and pain responses. This study will use brain imaging technology to examine the effects of a placebo intervention on µ-opioid neurotransmitters. Examination of the factors that regulate these placebo-activated neurotransmitter responses will clarify the overall neurobiology underlying variations in the responses to placebos, as well as pain and other stressful conditions, ultimately leading to the optimization of medical and psychological interventions.

This study will last several hours during one study visit. Participants will receive both a painful and a painless injection while undergoing positron emission tomography (PET) brain imaging. The painful injection will consist of small amounts of hypertoninc saline (concentrated saline that causes cell shrinkage) in the jaw muscle over a 20-minute period. Several minutes after participants receive hypertonic saline, they will receive an injection with isotonic saline not associated with pain in the opposite jaw muscle. After participants receive the injections, they will either be told or not be told about a pain relief intervention. PET imaging will continue as participants either anticipate or do not anticipate pain relief. Participants will be asked about their pain levels repeatedly throughout the study; their responses will be entered into a computer-controlled system which will modulate rates of saline infusion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Willing and able to comply with all study requirements

排除标准

  • Presence of pain at study entry
  • Personal or first-degree (e.g., mother, father, sister, brother) family history of neurologic or psychiatric disorders
  • History of substance abuse or dependence
  • Left-handed or ambidextrous
  • Positive urine toxicology screen
  • Acute or uncorrected medical illness that may interfere with the study
  • Unable to tolerate brain scanning procedures
  • Current treatment with antipsychotics, mood stabilizers, isoniazid (a drug for tuberculosis [TB]), glucocorticoids/mineralocorticoids, psychostimulant appetite suppressants, or centrally active antihypertensive drugs
  • Treatment with hormones, antidepressants, or opioids within 6 months prior to study entry
  • Treatment with sedative hypnotic medications or over-the-counter sleeping aids within 1 month prior to study entry
  • Diagnosis of depression
  • Competitive exercise, or exercise exceeding 1 hour each day
  • Regular smoking within 5 years prior to study entry

结局指标

主要结局

Placebo-induced activation of brain opioid neurotransmission

时间窗: 90 min

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon-Kar Zubieta

Professor

University of Michigan

研究点 (2)

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