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临床试验/NCT03631251
NCT03631251已完成早期 1 期

Enhancing Analgesia With Non-Deceptive Placebos: A Proof-Of-Concept Pilot Study

Brown University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年8月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Enrollment Percentage

研究概览

简要总结

America is in the midst of an opioid epidemic. One of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. If it is possible to develop new ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis.

Although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. In fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo.

The goal of the proposed study is to examine the feasibility of using an honest placebo to relieve pain for up to 20 real patients. People who are undergoing hand or wrist surgery or enrolled for upper extremity trauma in the Emergency Department and agree to participate will be asked to take placebo pills in addition to their standard course of opioid pills, given as part of standard care. Patients will also answer a few short questions over the phone once per day for seven days, and be invited to participate in an exit questionnaire at the end of the study. The investigators hypothesize that: 1) At least 50% of eligible participants will agree to enroll, 2) At least 80% of participants who are enrolled will be retained, and 3) Participants who are enrolled will take a placebo at least 50% of the time they also take an opioid pill

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Open Placebo

Experimental

Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.

干预措施: Open Placebo (Drug)

结局指标

主要结局

Enrollment Percentage

时间窗: Through study enrollment, 1 day

Percentage of Eligible Patients who Enroll

Retention Rate

时间窗: through study completion, approximately 2 months

Percentage of Patients who are Retained at follow-up

Placebo Intake

时间窗: 7 days

Number of Placebos Participants Take

Placebo Analgesia

时间窗: 7 days

Analgesia associated with placebo pills

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

Michael Bernstein

Postdoctoral Fellow

Brown University

研究点 (2)

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