An Innovative Intervention for OUD Treatment

OUD 治疗的创新干预措施

• 批准号: 10385750
• 负责人: Eric C. Strain
• 金额: $ 76.81万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10385750
• 关键词: Acute; Address; Adrenergic Agonists; Adverse effects; Adverse event; Agonist; Autonomic nervous system; Clinical; Clonidine; Controlled Clinical Trials; Controlled Study; Cranial Nerves; Data; Device Approval; Devices; Diagnosis; Dose; Ear; Effectiveness; Electrodes; Europe; Evaluation; FDA approved; Frequencies; Goals; Hour; Individual; Injections; Intervention; Maintenance; Medical; Methods; Multi-Institutional Clinical Trial; Naltrexone; Nerve; Opiate Addiction; Opioid; Opioid Antagonist; Oral; Pain; Participant; Pathway interactions; Patients; Peripheral; Persons; Pharmaceutical Preparations; Pharmacology; Physical Dependence; Placebos; Process; Public Health; Published Comment; Randomized; Randomized Controlled Clinical Trials; Reporting; Research; Risk; Role; Safety; Signs and Symptoms; Supervision; Testing; Thinking; Trigeminal nerve structure; United States; Withdrawal; Withdrawal Symptom; antagonist; comparative efficacy; comparison group; design; efficacy evaluation; efficacy testing; innovation; lofexidine; non-opioid analgesic; novel; novel strategies; opioid agonist therapy; opioid epidemic; opioid use disorder; opioid withdrawal; patient oriented; relating to nervous system; response; side effect; tool

This application proposes to conduct a randomized, controlled clinical trial to test the efficacy and safety of the Bridge Device (BD) when used for the treatment of opioid withdrawal. The BD is an FDA cleared tool that is currently marketed for the treatment of opioid withdrawal; preliminary evidence suggests it is effective and has a low risk for adverse effects. However, the product has not been tested against a sham control condition when used for opioid withdrawal treatment. Descriptive data provide evidence that it has effectiveness in suppressing opioid withdrawal, but there is a need to test the device under controlled conditions. In addition to testing the BD to a sham condition (SBD), the study includes a third condition – lofexidine. This is an FDA-approved medication for the treatment of opioid withdrawal, and this study will be the first direct comparison of two available non-mu opioid approaches that can be used to help transition patients off of opioid physical dependence. Novel mechanisms that assist in transitioning a person from physical dependence on opioids to a non-dependent state are needed – to address a patient-centered desire to live without maintenance on opioid agonist treatment (OAT), and/or to aid in the transition to antagonist treatment. Given the accumulating evidence for the efficacy of naltrexone (NTX), and especially extended release NTX, new and innovative ways to help patient stabilize on antagonist treatment are needed. The BD may serve a useful role in this process. The device is a percutaneous nerve field stimulator that has 4 electrodes placed on/near the ear, with wires to a small device that is worn behind the ear. The device targets 4 cranial nerves (V, VII, IX, and X) that have auricular branches, and it provides alternating low-grade electrical frequencies to these nerves as a means for peripheral stimulation of the specific cranial nerves. Stimulation by the device is hypothesized to provide central nervous modulation of pain paths. When used clinically, the device is worn continuously for 5 days, and reports of its use indicate that it provides relief of opioid withdrawal within approximately an hour of placement. The primary goal of this study is to demonstrate that the BD is more effective than a sham control condition in suppressing opioid withdrawal signs and symptoms, and a secondary aim is to determine its relative efficacy compared to lofexidine. Participants will be persons physically dependent on opioids, with a diagnosis of OUD, and who agree to reside on a residential unit for the study duration. At the end of the residential stay, participants will be offered oral naltrexone treatment, and the option of transition on to XR-NTX. Given the magnitude of the opioid crisis in the United States, and the need to both expand treatment options as well as mechanisms that can facilitate the transition on to antagonist treatments, the BD has the potential to have substantial impact and public health significance. In addition, expanding the treatment of OUD to effective devices can open up new thinking and approaches that are not based solely on pharmacological approaches to this devastating medical illness.

该申请提案要进行随机，对照临床试验，以测试 桥梁装置（BD）用于治疗阿片类药物的戒断。 BD是FDA清除的工具 目前被销售用于治疗阿片类药物的戒断；初步证据表明它是有效的，并且 不良影响的低风险。但是，当产品尚未针对假控制条件进行测试 用于阿片类药物戒断治疗。描述性数据提供了证据表明它在抑制中具有有效性 阿片类药物提取，但需要在受控条件下测试设备。除了测试 BD到假条件（SBD），该研究包括第三个疾病 - 洛芬己定。这是FDA批准的 用于治疗阿片类药物的药物，这项研究将是两个直接比较 可用的非MU Ooid方法可用于帮助过渡患者从OID物理 依赖。新型机制有助于将人从对阿片类药物的身体依赖转变为 需要非依赖状态 - 以解决以患者为中心的渴望在没有维护的情况下生活的愿望 激动剂治疗（OAT）和/或有助于过渡到拮抗剂治疗。考虑到积累 纳曲酮（NTX）的效率的证据，特别是扩展的NTX，新的和创新的方式 为了帮助患者稳定拮抗剂治疗。 BD在此过程中可能发挥有用的作用。 该设备是一种经皮神经场刺激器，在耳朵附近/附近有4个电子，带有电线 耳朵后面穿着的小型设备。该设备靶向具有4个颅神经（V，VII，IX和X） 耳神分支，并为这些神经提供替代的低级电频率 特定颅神经的周围刺激。假设设备刺激以提供 中枢神经调节疼痛路径。在临床上使用时，将设备连续磨损5天，并且 有关其使用的报告表明，它在放置大约一个小时内可以缓解阿片类药物的戒断。 这项研究的主要目标是证明BD比假控制条件更有效 抑制阿片类药物的提取体征和符号，次要目的是确定其相对效率 与Lofexidine相比。参与者将是身体上依赖阿片类药物的人，并诊断出OUD， 并同意在研究期间居住在住宅单位上。在住宿结束时， 参与者将获得口服纳曲酮治疗，并选择过渡到XR-NTX。鉴于 美国阿片类药物危机的大小，以及扩大治疗方案的需求 可以促进过渡到拮抗剂治疗的机制，BD有可能具有 实质性影响和公共卫生意义。此外，将OUD的处理扩展到有效 设备可以打开不仅基于药品方法的新思维和方法 对这种毁灭性的医学疾病。