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

基本信息

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
项目类别：
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

项目摘要

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，美国正在经历阿片类药物在处方药和非处方药中的流行自 2005 年以来，慢性疼痛的药物数量持续增加。每天接受阿片类药物长期治疗的参与者阿片类药物消费量持续增加。从 2005 年到 2017 年，这一数字现在可能超过 1100 万，不幸的是，对安全和安全的需求。有效的阿片类药物戒断治疗要求很高，而且基本上尚未得到满足。药物治疗接受者总体百分比的主要限制是可用性有限可以开阿片类药物处方的持证医生的数量构成了一个变量。呼吸抑制和心脏活动异常的风险水平，只能从获得许可的地方获得相比之下，非阿片类药物治疗（洛非西丁和纳曲酮）不需要。许可证，并有可能得到更广泛的管理，但治疗效果和保留率。这些药物的数量有限，因此与阿片类药物治疗相比，使用非阿片类药物的患者明显较少。由于治疗选择不充分且稀缺，寻找有效的非药物方法可以： 1) 需要最少的培训，2) 随时可供医生和高级护理提供者使用，3) 需要最少的培训副作用概况，4) 防止或消除阿片类药物的使用，以及 5) 消除对经历的恐惧急性/突然戒断对于改善和扩大阿片类药物成瘾的治疗至关重要。大量的临床证据表明可以快速有效地减少与以下疾病相关的体征和症状：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廓神经刺激（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。 Spark Biomedical Inc. 开发了一种 tAN 系统，消除了经皮穿刺的局限性 Spark 的 SparrowTM 治疗系统采用带有嵌入式的灵活耳机。水凝胶电极粘附在皮肤上，耳机在使用后是一次性的，提供更舒适的佩戴体验此外，该系统能够完全定制刺激参数以匹配。制定了激活耳脑神经分支的每个参与者的治疗要求。通过 tAN 可以类似地减少阿片类药物戒断症状，减少经皮皱纹神经刺激。 Sparrow 系统是一种可穿戴、电池供电的神经刺激设备，旨在经皮刺激耳朵内和/或周围的神经麻雀目前被认为是经皮神经。有助于减少阿片类药物戒断症状的刺激器这项工作的目标是扩大范围。使用我们的 Sparrow 系统来减少对阿片类药物的渴望并减少复发的机会。