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戒断中的应用 解释干预和感觉获取计划；以及(2)面向提供者的门户网站，用于 社会弱势群体和性少数群体的物质使用障碍治疗。管理 物质使用障碍(SUD)主要涉及患者和提供者之间的直接接触，但 新冠肺炎大流行的先例提高了以患者为中心的SUD远程管理的必要性。 虽然数字治疗和移动健康平台提供了远程管理的途径，但我们的 非裔美国人(AA)、西班牙裔美国人(HA)和其他社会弱势群体 人们在采用这些移动平台方面滞后，原因是不识字、数字文盲、无法访问 智能手机，缺乏可靠的Wi-Fi或互联网，以及资金紧张。此外，虽然干预措施 存在阿片类药物使用障碍(OUD)，没有治疗可卡因或兴奋剂使用障碍的药物。服务不足 有性行为障碍的AA和HA社区，特别是被边缘化的男男性行为者(MSM)，拥有更多 严重共存的可卡因、甲基苯丙胺和酒精使用障碍；以及针对这些的数字解决方案 人口稀缺。另一方面，提供商缺乏适应良好的、基于智能的生理和 心理物理获取平台，以指导阿片类药物和酒精戒断的远程激动剂管理。 通过第一阶段的SBIR，Evon Medics开发了一种基于数字化学传感的组合眼眶前额 皮质阿片类药物使用障碍训练(CBOT)。基于CBOT对我们的社会的限制 针对弱势AA、HA和MSM人群，我们最近修订了兴奋剂和MSM的治疗平台 酒精使用障碍，包括β-石竹烯化学感觉刺激。我们提出了进一步的产品 开发，对面向患者的平台和面向提供商的新平台进行创新更改，以 指导对吸毒、兴奋剂(可卡因和甲基苯丙胺)使用和酒精使用障碍的远程管理 通过快速通道SBIR资金。在第一阶段，我们将为面向患者的平台配置：语音 不同语言的命令，特别适用于不会说英语、不使用Wi-Fi或依赖互联网的用户 连通性解决方案和可靠的瞳孔、脉搏、其他生理和心理(例如，渴望) 获取；以及面向提供商的组件，在HIPAA-Secure中提供对患者数据的解释 传送门。我们将在附属物质使用社区项目和社区进行初步测试 华盛顿特区和马里兰州服务不足社区的人口。在第二阶段，我们将执行一项 EDITOR与常规治疗和CBOT办公室治疗的试点随机试验比较 与埃文医学院和霍华德大学相关的几个联邦资助项目中的肥皂水。vt.在.的基础上 完成第一阶段和第二阶段，我们将准备将研究扩大到更大的第三阶段疗效 研究或实施研究通过商业伙伴关系在现实世界环境中的有效性 在这个项目的过程中开发的。据我们所知，这将是对 基于数字化学传感器的平台，用于远程管理SUD，文化上适合社交 处境不利的社区和人口。

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) a 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 an 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 with different languages especially for the non-English speaking, non-Wi-Fi or internet-dependent connectivity solution and reliable pupillary, pulse rate, other physiological and psychological (e.g., craving) acquisitions; and the provider-facing component to provide interpretation of patients’ data in a HIPAA-secure portal. We will do preliminary testing in affiliated substance use community programs and community populations in the under-served communities in Washington, DC and Maryland. 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.