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

目前，美国在处方药和非处方药的使用上正经历阿片类药物的流行 自20世纪90年代以来，毒品价格一直在上涨。2005年，估计有1000万慢性疼痛患者 每天接受阿片类药物长期治疗的参与者。阿片类药物消费的持续增加 从2005年到2017年，这一数字现在可能超过1 100万。不幸的是，安全和 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百分比的主要限制因素是可用性有限 有执照的医生可以开基于阿片类药物的药物治疗。处方阿片类药物构成变量 呼吸抑制和心脏活动异常的风险水平，只能从有执照的 阿片类药物治疗计划。相比之下，非阿片类药物治疗（洛非西定和纳洛酮）不需要 许可证，并有可能得到更广泛的管理。然而，治疗效果和保留 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明显少于阿片类药物治疗的患者。 由于治疗选择不足和稀缺，找到了一种有效的非药物方法，可以： 1)需要最少的培训，2）随时提供给医生和高级护理提供者，3）具有最少的 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/突然戒断对于改进和扩大类阿片成瘾治疗至关重要。 有大量的临床证据表明，快速有效地减少与下列症状相关的体征和症状： 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神经刺激（tANTM）作为非阿片类药物的辅助治疗。 药物治疗，以改善治疗保留，进一步减少阿片类药物戒断症状和渴望。 Spark Biomedical Inc.开发了一种tAN系统，消除了经皮穿刺的局限性， 神经刺激系统Spark的SparrowTM治疗系统采用嵌入式弹性耳机 水凝胶电极粘附在皮肤上，耳机在使用后是一次性的，并提供更舒适的 和实际治疗此外，该系统能够完全定制刺激参数以匹配 每个参与者的治疗需求。假设激活耳颅神经分支 通过tAN将赋予阿片类戒断症状类似的减少，减去经皮给药的缺点， 神经刺激 Sparrow系统是一种可穿戴、电池供电的神经刺激器械，预期用于 刺激耳朵内和/或周围的神经。Sparrow目前适用于经皮神经 刺激剂，有助于减少阿片类药物戒断症状。这项工作的目标是扩大 使用我们的麻雀系统减少阿片类药物的渴望和减少复发的机会。

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.