Delivering Transcutaneous Auricular Neurostimulation to Improve Treatment Retention in Opioid Use Disorder

提供经皮耳廓神经刺激以改善阿片类药物使用障碍的治疗保留

• 批准号: 10456147
• 负责人: Navid Khodaparast
• 金额: $ 124.67万
• 依托单位: SPARK BIOMEDICAL INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456147
• 关键词: Acute; Adjuvant; Adverse event; Aftercare; Agonist; American; Antihypertensive Agents; Buprenorphine; Cardiac; Clinical; Clinical Research; Clonidine; Cranial Nerves; Custom; Data; Dependence; Devices; Drug usage; Ear; Electrodes; FDA approved; Fright; Goals; Health; Heart Abnormalities; Hydrogels; Licensing; Measures; Methadone; Naltrexone; Nerve; Non-Prescription Drugs; Opiate Addiction; Opioid; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Phase; Physicians; Placebos; Prevention; Randomized; Recording of previous events; Relapse; Residential Treatment; Risk; Safety; Signs and Symptoms; Skin; Sparrows; Surveys; System; Therapeutic; Time; Training; Treatment Efficacy; United States; Ventilatory Depression; Withdrawal; Withdrawal Symptom; alpha 2 agonist; antagonist; associated symptom; base; care providers; chronic pain; craving; experience; flexibility; improved; lofexidine; non-opioid analgesic; opioid epidemic; opioid treatment program; opioid use; opioid use disorder; opioid withdrawal; phase 2 study; phase I trial; phase II trial; prescription opioid; prevent; prospective; reduce symptoms; retention rate; side effect; treatment comparison; treatment program; treatment trial

Currently, the United States is experiencing an opioid epidemic in the use of prescription and non-prescription drugs that has continued to rise since the 1990’s. In 2005, there were an estimated 10 million chronic pain participants receiving daily, long-term treatment with opioids. The continuing increase in opioid consumption from 2005 to 2017 suggests that the number may now exceed 11 million. Unfortunately, the need for safe and effective opioid withdrawal treatment is demanding and largely unmet. A primary constraint on the overall percentage of pharmacotherapy treatment recipients is the limited availability of licensed physicians that can prescribe opioid-based pharmacotherapies. Prescription opioids pose a variable level of risk on respiratory depression and abnormal cardiac activity and can only be obtained from licensed opioid treatment programs. In contrast, non-opioid pharmacotherapies (lofexidine and naltrexone) do not require a license, and have the potential to be more widely administered. However, the treatment efficacy and retention of these medications are limited, thus significantly fewer patients utilize non-opioid vs opioid pharmacotherapies. Due to inadequate and scarce treatment options finding an effective, non-pharmacological approach that would: 1) require minimal training, 2) be readily available to physicians and advanced care providers, 3) have a minimal side effects profile, 4) prevent or eliminate the use of opioids, and 5) remove the fear of experiencing acute/precipitated withdrawal would be critical in improving and expanding treatment for opioid addiction. Abundant clinical evidence exists for the rapid and effective reduction of signs and symptoms associated with opioid withdrawal through various approaches of non-invasive neurostimulation. We propose using transcutaneous auricular neurostimulation (tANTM) as an adjuvant to non-opioid pharmacotherapies to improve treatment retention by further reducing opioid withdrawal symptoms and cravings. Spark Biomedical Inc., has developed a tAN system, that removes the limitations of percutaneous neurostimulation systems. Spark’s SparrowTM Therapy System utilizes a flexible Earpiece with embedded hydrogel electrodes that adhere to the skin, the Earpiece is disposable after use, and delivers a more comfortable and practical therapy. Additionally, this system is capable of fully customizing stimulation parameters to match each participants’ therapeutic requirements. It was hypothesized that activating auricular cranial nerve branches via tAN would confer a similar reduction in opioid withdrawal symptoms, minus the drawbacks of percutaneous neurostimulation. The Sparrow System is a wearable, battery-operated, neurostimulation device intended to transcutaneously stimulate nerves in and/or around the ear. The Sparrow is currently indicated as a transcutaneous nerve stimulator that aids in the reduction of opioid withdrawal symptoms. The goal of this proposed effort is to expand the use of our Sparrow System for the reduction in opioid cravings and lessen the chance of relapse.

目前，美国正在经历处方药和非处方药使用中的阿片类药物流行 自1990年S以来，药物持续上升。2005年，估计有1000万慢性疼痛 参与者每天接受长期阿片类药物治疗。阿片类药物消费的持续增长 从2005年到2017年，这一数字可能会超过1100万。不幸的是，安全和安全的需要 有效的阿片类药物戒断治疗要求很高，而且基本上没有得到满足。 药物治疗接受者总体比例的一个主要制约因素是可获得性有限 可以开出阿片类药物治疗处方的执业医生。处方阿片类药物构成了一个变量 呼吸抑制和心脏活动异常的风险水平，只能从有执照的人那里获得 阿片类药物治疗方案。相比之下，非阿片类药物疗法(洛非西定和纳曲酮)不需要 许可证，并有可能得到更广泛的管理。然而，治疗的疗效和滞留率 这些药物的使用是有限的，因此使用非阿片类药物治疗的患者比使用阿片类药物治疗的患者要少得多。 由于缺乏足够和稀少的治疗选择，找到一种有效的非药理学方法将： 1)需要最低限度的培训，2)医生和高级护理提供者随时可用，3)有最低限度的 副作用简介，4)防止或消除阿片类药物的使用，5)消除经历的恐惧 急性/急促戒断将是改善和扩大阿片成瘾治疗的关键。 有大量的临床证据表明，快速有效地减少与 通过各种非侵入性神经刺激方法戒断阿片类药物。 我们建议使用经皮耳神经刺激(TANTM)作为非阿片类药物的佐剂。 药物疗法通过进一步减少阿片类药物戒断症状和渴望来改善治疗保留率。 Spark Biomedical Inc.已经开发出一种TAN系统，它消除了经皮穿透的限制 神经刺激系统。Spark的SparrowTM治疗系统使用嵌入式柔性耳机 水凝胶电极附着在皮肤上，耳机使用后即可一次性使用，并提供更舒适的 和实用的治疗。此外，该系统能够完全定制刺激参数以匹配 每个参与者的治疗要求。据推测，激活耳颅神经分支 Via Tan可以类似地减少阿片类药物戒断症状，但不包括经皮穿刺法的缺点 神经刺激。 Sparrow系统是一种可穿戴的、由电池供电的神经刺激设备，旨在通过皮肤 刺激耳朵内和/或周围的神经。麻雀目前被认为是一种经皮神经 有助于减少阿片类药物戒断症状的刺激剂。这项拟议的努力的目标是扩大 使用我们的麻雀系统来减少阿片类药物的渴望，减少复发的机会。