The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)

摘要 基于数字化学感官的增强型嗅觉训练系统的研制与评价 远程管理物质使用障碍(编辑)是一个项目，开发一个可持续的，可扩展的， 和以患者为中心的移动健康平台，包括(1)面向患者、适应文化的数字- 刺激剂、酒精和阿片类药物使用障碍的化学感觉疗法，获取目标的传感器 物质中毒和戒断的生理测量及其在跑步和解译中的应用 干预和感觉获取计划；以及(2)面向提供者的门户网站，用于物质使用 社会弱势群体和性少数群体的障碍治疗。物质使用管理 疾病(SUD)主要涉及患者和提供者之间的直接接触，但COVID的优先顺序是- 19大流行提高了以患者为中心的SUD远程管理的需要。在数字化的同时 治疗和移动医疗平台为远程管理提供了途径，我们的非洲社区 美国人(AA)、西班牙裔美国人(HA)和其他社会弱势群体在采用 这些移动平台，由于不识字、数字文盲、无法使用智能手机、 可靠的Wi-Fi或互联网，以及财务限制。此外，虽然存在阿片类药物使用障碍的干预措施 (OUD)，没有治疗可卡因或兴奋剂使用障碍的药物。服务不足的机管局和医管局社区 OUD，特别是被边缘化的男男性行为者(MSM)，有更严重的可卡因共存， 甲基苯丙胺和酒精使用障碍；缺乏针对这些人群的数字解决方案。提供者 另一方面，缺乏适应性强、智能化的生理和心理物理采集平台 指导阿片类药物和酒精戒断的远程激动剂管理。通过第一阶段SBIR，Evon医护人员 开发一种基于数字化学感觉的阿片类药物使用障碍的组合式数字眼眶前额叶皮质训练 (芝加哥期货交易所)。基于CBOT对社会弱势群体AA、HA和MSM的限制，我们 最近修订了兴奋剂和酒精使用障碍治疗平台，纳入了β- 石竹烯化学感官刺激。我们建议进一步开发产品，并进行创新，以 面向患者的平台和面向提供者的新平台，用于指导OUD、兴奋剂的远程管理 (可卡因和甲基苯丙胺)使用和酒精使用障碍，通过快速通道SBIR资金。在第一阶段， 我们将在面向患者的平台上配置：语音命令，不同的语言，特别是针对非 会说英语，非Wi-Fi或依赖互联网的连接解决方案，可靠的瞳孔，脉搏和SpO2 生理获取和心理(例如，渴望)调查；以及面向提供者的组成部分 在HIPAA安全门户中提供对患者数据的解释。我们将在三个方面进行初步测试 使用计划、霍华德大学急诊室和服务不足的8号病房的社区人口 华盛顿特区的社区。在第二阶段，我们将进行EDITOR的试点随机试验，将其与 在几个联邦资助项目中，常规治疗和CBOT用于肥皂症的办公室治疗 与埃文医学院和霍华德大学有关。在第一和第二阶段完成后，我们将准备 将研究扩展到更大的第三阶段疗效研究，或#年有效性的实施研究 在这个项目的过程中，通过商业伙伴关系发展的现实世界的背景。尽最大努力 据我们所知，这将是第一次评估基于数字化-化学传感的远程平台 在文化上适应社会弱势群体和人口的南方发展的管理。

ABSTRACT The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) is a project to develop a sustainable, scalable, and patient-centered mobile health platform, comprised of (1) patient-facing culturally-adapted digital- chemosensory therapeutic for stimulant, alcohol and opioid use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and application for running and interpreting the interventions and sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially-disadvantaged and sexual minority populations. Management of substance use disorders (SUD) mostly involve direct contact between patients and providers, but the precedence of COVID- 19 pandemic has elevated the need for patient-centered remote management of SUD. While digital therapeutics and mobile health platforms provide avenues for remote management, our communities of African Americans (AA), Hispanic-Americans (HA) and other socially disadvantaged populations lag in adoption of these mobile platforms, due to inability to read, digital illiteracy, lack of access to smartphones, absence of reliable Wi-Fi or internet, and financial constraints. Moreover, while interventions exist for Opioid Use Disorders (OUD), there are no drugs for cocaine or stimulant use disorders. Underserved AA and HA communities with OUD, particularly marginalized men who have sex with men (MSM), have more severe co-existing cocaine, methamphetamine, and alcohol use disorders; and digital solutions for these populations are lacking. Providers on the other hand, lack well-adapted, intelligent-based physiological and psychophysical acquisition platforms to guide remote agonist management of opioid and alcohol withdrawal. Through Phase I SBIR, EVON Medics developed a combinatorial digital chemosensory-based orbitofrontal cortex training for Opioid Use Disorder (CBOT). Based on the limitations of CBOT for our socially disadvantaged AA, HA and MSM population, we recently revised the platform for treatment of stimulant and alcohol use disorder, by including beta- caryophyllene chemosensory stimulation. We propose further product development, with innovative changes to the patient-facing platform and a new provider-facing platform to guide remote management of OUD, Stimulant (cocaine and methamphetamine) use and alcohol use disorders through Fast-Track SBIR funding. In Phase I, we will configure the patient-facing platform with: voice commands, different languages especially for the non- English speaking, non-Wi-Fi or internet-dependent connectivity solution, reliable pupillary, pulse rate and spo2 physiological acquisitions and psychological (e.g., craving) surveys; and the provider-facing component to provide interpretation of patients’ data in a HIPAA-secure portal. We will do preliminary testing in 3 substance use programs, Howard University emergency room, and community populations in the under-served Ward 8 communities in Washington, DC. In Phase II, we will perform a pilot randomized trial of EDITOR compared to treatment as usual and CBOT for office-based treatment of SUDs in several federal funded programs associated with Evon Medics and Howard University. Upon completion of Phases I and II, we will be poised to expand the research to either a larger, Phase III efficacy study, or an implementation study of effectiveness in the real-world setting through commercial partnerships developed over the course of this project. To the best of our knowledge, this will be the first evaluation of Digital-Chemosensory-Based platform for remote management of SUD, culturally adapted for socially disadvantaged communities and populations.