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.

本申请拟进行一项随机对照临床试验，以测试该药物的有效性和安全性。 用于治疗阿片类药物戒断的桥接装置 (BD) BD 是 FDA 批准的工具。 目前上市用于治疗阿片类药物戒断；初步证据表明它是有效的，并且已得到证实。 不良反应的风险较低，但该产品尚未针对假对照条件进行测试。 用于阿片类药物戒断治疗的描述性数据提供了其有效抑制的证据。 阿片类药物戒断，但除了测试设备外，还需要在受控条件下测试设备。 BD 为假条件 (SBD)，该研究包括第三种条件——洛非西丁，这是 FDA 批准的一种药物。 用于治疗阿片类药物戒断的药物，这项研究将是首次直接比较两种药物 可用的非 mu 阿片类药物方法可用于帮助患者摆脱阿片类药物的物理治疗 有助于将人从对阿片类药物的身体依赖转变为阿片类药物依赖的新机制。 需要非依赖性状态——以满足以患者为中心的、无需维持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。 纳曲酮 (NTX)，尤其是缓释 NTX 功效的证据，新的和创新的方法 BD 可能会在这一过程中发挥有用的作用。 该设备是一种经皮神经场刺激器，有 4 个电极放置在耳朵上/附近，并通过电线连接 戴在耳后的小型设备 该设备针对 4 条脑神经（V、VII、IX 和 X）。 耳分支，它为这些神经提供交替的低级电频率，作为一种手段 设备对特定脑神经的外周刺激竞相提供。 疼痛路径的中枢神经调节 当临床使用时，该装置连续佩戴 5 天，并且 其使用报告表明，它可以在放置后大约一小时内缓解阿片类药物戒断症状。 本研究的主要目标是证明 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功效 与洛非西定相比，参与者将是身体依赖阿片类药物且诊断为 OUD 的人， 并同意在学习期间居住在住宅单元中，在住宅住宿结束时， 参与者将接受口服纳曲酮治疗，并可选择过渡到 XR-NTX。 美国阿片类药物危机的严重性，以及扩大治疗选择和 可以促进向拮抗剂治疗过渡的机制，BD 有潜力 此外，扩大 OUD 的治疗以有效。 设备可以开辟新的思维和方法，而不仅仅基于药理学方法 对于这种毁灭性的医学疾病。