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

用于药物使用障碍远程管理的增强型数字化学感应嗅觉训练的开发和评估（编辑）

• 批准号: 10741580
• 负责人: Charles Chiedu Nwaokobia
• 金额: $ 5.5万
• 依托单位: EVON MEDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10741580
• 关键词: Accident and Emergency department; Adoption; African American population; Agonist; Alcohol withdrawal syndrome; Beta-caryophyllene; COVID-19 pandemic; Cellular Phone; Cocaine; Cocaine use disorder; Communities; Data; Development; Disadvantaged minority; Disparity population; Evaluation; Feedback; Funding; Health Insurance Portability and Accountability Act; Hispanic Americans; Industry; Innovation Corps; Intelligence; Internet; Intervention; Intoxication; Language; Leadership; Measures; Mentorship; Methamphetamine; Methamphetamine use disorder; Patients; Pharmaceutical Preparations; Phase; Physiological; Population; Provider; Psychophysics; Pulse Rates; Remote management; Research; Running; Secure; Sensory; Small Business Innovation Research Grant; Stimulant; Substance Use Disorder; Surveys; Testing; Therapeutic; Training; Universities; Voice; Washington; Withdrawal; alcohol use disorder; cocaine use; combinatorial; craving; digital; digital treatment; effectiveness/implementation study; efficacy study; illiteracy; innovation; mHealth; marginalization; men who have sex with men; mobile computing; neighborhood disadvantage; opioid use disorder; opioid withdrawal; patient oriented; product development; programs; psychologic; randomized trial; sensor; sexual minority group; social disparities; stimulant use; stimulant use disorder; substance use; substance use treatment; treatment as usual; ward; web portal; wireless fidelity

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.

抽象的 增强型数字化学感应嗅觉训练的开发和评估 药物使用障碍远程管理 (EDITOR) 是一个开发可持续、可扩展、 以患者为中心的移动医疗平台，包括 (1) 面向患者、文化适应的数字化平台 用于兴奋剂、酒精和阿片类药物使用障碍的化学感应治疗，用于获取目标的传感器 物质中毒和戒断的生理测量，以及跑步和解释的应用 干预措施和感官获取计划；以及 (2) 面向提供者的药物使用门户网站 社会弱势群体和性少数群体的疾病治疗 药物使用管理。 疾病 (SUD) 主要涉及患者和提供者之间的直接接触，但新冠肺炎的优先级 19 大流行增加了以患者为中心的 SUD 数字化远程管理的需求。 治疗和移动医疗平台为远程管理、我们的非洲社区提供了途径 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，由于无法阅读、数字文盲、无法使用智能手机、缺乏 此外，虽然存在针对阿片类药物使用障碍的干预措施。 (OUD)，没有针对可卡因或兴奋剂使用障碍的药物。 AA 和 HA 社区服务不足。 OUD，特别是男男性行为者（MSM），有更严重的共存可卡因， 甲基苯丙胺和酒精使用障碍；以及缺乏针对这些人群的数字解决方案。 另一方面，缺乏适应性强、智能化的生理心理采集平台 通过第一阶段 SBIR，EVON Medics 指导阿片类药物和酒精戒断的远程激动剂管理。 开发了一种基于组合数字化学感应的眶额皮层训练，用于治疗阿片类药物使用障碍 (CBOT) 基于 CBOT 对于社会弱势 AA、HA 和 MSM 人群的局限性，我们 最近修订了治疗兴奋剂和酒精使用障碍的平台，纳入了β- 我们建议进一步开发石竹烯化学感应刺激，并进行创新性改变。 面向患者的平台和一个新的面向提供商的平台，用于指导 OUD、Sstimulant 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， 我们将配置面向患者的平台：语音命令、不同的语言，特别是对于非 讲英语、非 Wi-Fi 或依赖互联网的连接解决方​​案、可靠的瞳孔、脉搏率和 spo2 生理获取和心理（例如渴望）调查以及面向提供者的部分； 在 HIPAA 安全门户中提供患者数据的解释 我们将进行 3 种物质的初步测试。 使用计划、霍华德大学急诊室以及服务不足的 8 号病区的社区人口 在第二阶段，我们将在华盛顿特区的社区中进行一项 EDITOR 的试点随机试验。 照常治疗和 CBOT 在几个联邦资助的项目中对 SUD 进行办公室治疗 与 Evon Medics 和霍华德大学合作，第一阶段和第二阶段完成后，我们将做好准备。 将研究扩展到更大规模的 III 期疗效研究，或有效性的实施研究 通过在该项目过程中建立的商业伙伴关系来实现现实世界的设置。 据我们所知，这将是对基于数字化学感应的远程平台的首次评估 SUD 的管理，在文化上适应社会弱势社区和人群。