An Innovative Intervention for OUD Treatment

OUD 治疗的创新干预措施

• 批准号: 10222636
• 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10222636
• 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; 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.

本申请拟进行随机对照临床试验，以检测 桥接装置（BD）用于治疗阿片类药物戒断。BD是FDA批准的工具， 目前已上市用于治疗阿片类药物戒断;初步证据表明，它是有效的， 不良反应的风险较低。但是，本产品尚未在假对照条件下进行试验， 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 阿片类药物戒断，但有必要在受控条件下测试该设备。除了测试 BD至假手术条件（SBD），该研究包括第三种条件-洛非西定。这是FDA批准的 药物治疗阿片类药物戒断，这项研究将是第一个直接比较两个 现有的非μ阿片类药物方法可用于帮助患者从阿片类药物物理治疗过渡 依赖新的机制，有助于将一个人从对阿片类药物的身体依赖转变为 需要非依赖状态-以满足以患者为中心的不依赖阿片类药物维持生活的愿望 激动剂治疗（OAT），和/或帮助过渡到拮抗剂治疗。鉴于累积的 纳洛酮（NTX），特别是延长释放NTX，新的和创新的方法， 以帮助患者稳定拮抗剂治疗。屋宇署在这过程中可发挥有用的作用。 该设备是一种经皮神经场刺激器，具有放置在耳朵上/附近的4个电极， 戴在耳朵后面的小装置。该器械针对4个颅神经（V、VII、IX和X）， 耳支，它提供交替的低等级电频率，这些神经作为一种手段， 特定颅神经的外周刺激。假设器械刺激可提供 疼痛路径的中枢神经调节。临床使用时，连续佩戴5天， 关于其使用的报告表明，它在放置后约一小时内缓解阿片类药物戒断症状。 本研究的主要目的是证明BD比假对照条件更有效， 抑制阿片类药物戒断体征和症状，次要目的是确定其相对疗效 与洛非西定相比。参与者将是身体依赖阿片类药物的人，诊断为OUD， 并同意在研究期间居住在住宅单位。在住宿结束时， 参与者将被提供口服纳洛酮治疗，并选择过渡到XR-NTX。鉴于 美国阿片类药物危机的严重性，以及扩大治疗选择的必要性， 由于可以促进向拮抗剂治疗过渡的机制，BD有可能具有 重大影响和公共卫生意义。此外，扩大OUD的治疗范围， 设备可以开辟新的思路和方法，而不仅仅是基于药理学方法 这种毁灭性的疾病。