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临床试验/NCT03489161
NCT03489161已完成早期 1 期

The Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年8月1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
3
试验地点
1
主要终点
Acceptability of transferral to outpatient clinic (MOTIVATE)

研究概览

简要总结

The investigators are trying to determine whether they can effectively treat patients suffering from acute opioid withdrawal in the Emergency Department at Virginia Commonwealth University Health System (VCUHS) and subsequently transfer them to an outpatient addiction clinic within the existing infrastructure. This will be a descriptive investigation of the process to reveal areas of success and opportunities for improvement in order to determine feasibility of the study procedures in preparation for a larger clinical investigation.

详细描述

Currently, patients in the Emergency Department at VCUHS experiencing opioid withdrawal, after reversal of opioid intoxication by naloxone, do not receive any direct treatment to stop the symptoms. They do receive indirect treatment aimed at each specific symptom, such as an anti-emetic to stop vomiting. The investigators propose directly treating all of the symptoms with the medication Suboxone, (buprenorphine/naloxone). Buprenorphine is a partial agonist on the Mu-receptor, which means it will provide less opioid effect than morphine, but should provide enough to make opioid withdrawal more tolerable. This is very important because stopping the withdrawal symptoms early will prevent the patient from quickly leaving and using opioids again, continuing their addiction cycle. The naloxone is included with buprenorphine as a deterrent to prevent intravenous injection of the drug for abuse. The investigators believe that if the patient is treated with Suboxone for withdrawal in the emergency department, and transported to the outpatient addiction treatment center at VCU, called the MOTIVATE clinic, the investigators can potentially break that cycle and help the patient work toward recovering. If successful, the investigators hope to improve the quality of life, prevent further overdose and death in those suffering from this deadly addiction.

Buprenorphine effectively treats the opioid withdrawal state. This has been demonstrated in many studies during the initial induction period with buprenorphine. Many of these patients are experiencing opioid withdrawal during this time. The sublingual dose can effectively be increased to resolve symptoms. According to many protocols and guidelines, acute opioid withdrawal is the preferred state of the patient when buprenorphine should be started.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Opioid overdose only, of any formulation or route, with complete reversal of toxicity after naloxone by any route.
  • Pulse oximetry > 95%
  • Clinical Opioid Withdrawal Scale (COWS) score ≥ 8

排除标准

  • Pregnancy
  • Incomplete reversal of toxicity related to metrics above
  • Police custody
  • Known allergy to buprenorphine
  • Emergent psychiatric condition including active suicidality that requires admission
  • Emergent medical condition that requires admission

研究组 & 干预措施

Buprenorphine

Experimental

Buprenorphine administered in the emergency room after patients presenting to the emergency department (ED) due to opioid OD who have been treated with opioid antagonist (naloxone) and are stable and alert.

干预措施: Buprenorphine (Drug)

结局指标

主要结局

Acceptability of transferral to outpatient clinic (MOTIVATE)

时间窗: 48 hours

Percentage of eligible participants who complete additional screenings at MOTIVATE

Recruitment rates

时间窗: Baseline

Percentage of eligible potential participants who enroll in study

次要结局

  • Feasibility of 5-Trial Delay Discounting(Prior to drug administration (within 2 hours after participant is stabilized and consented))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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