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.

摘要 基于数字化感觉的嗅觉训练的开发与评价 物质使用障碍的远程管理（EDITOR）是一个项目，以开发一个可持续的，可扩展的， 和以患者为中心的移动的健康平台，包括（1）面向患者的适应文化的数字- 用于兴奋剂、酒精和阿片类药物使用障碍的化学感觉治疗剂、用于获得目标的传感器 物质中毒和戒断的生理学测量以及在跑步和解释中的应用 干预和感觉获得计划;（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疾病治疗。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- 19大流行提高了对以患者为中心的SUD远程管理的需求。而数字 治疗和移动的健康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 这些移动的平台，由于无法阅读，数字文盲，缺乏智能手机，缺乏 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AA和HA社区， OUD，特别是与男性发生性关系的边缘化男性（MSM），有更严重的共存可卡因， 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。提供商 另一方面，缺乏适应性强的、基于智能的生理和心理物理获取平台 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 Medics 开发了一种基于组合数字化学传感器的眶额皮层训练阿片类药物使用障碍 （CBOT）。基于CBOT对我们的社会弱势AA，HA和MSM人群的限制，我们 最近修订了治疗兴奋剂和酒精使用障碍的平台， 卡环烯化学感觉刺激我们建议进一步开发产品，并进行创新性的更改， 面向患者的平台和新的面向提供者的平台，用于指导OUD、刺激剂的远程管理 （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， 我们将为面向患者的平台配置：语音命令，不同的语言，特别是针对非 英语，非Wi-Fi或互联网依赖的连接解决方案，可靠的瞳孔，脉搏率和spo 2 生理采集和心理（例如，渴望）调查;和面向提供者的组件， 在HIPAA安全门户中提供患者数据的解释。我们将在3个物质中进行初步测试 使用程序，霍华德大学急诊室，和社区人口在服务不足的病房8 在华盛顿的社区。在第二阶段，我们将进行EDITOR的试点随机试验， 在几个联邦资助的项目中，常规治疗和CBOT用于SUD的办公室治疗 与埃文医生和霍华德大学有联系。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III期疗效研究，或 通过在这个项目的过程中发展的商业伙伴关系的现实世界的设置。尽最大 据我们所知，这将是第一次评估基于数字化学传感器的远程平台， 在文化上适应社会弱势社区和人口的可持续发展管理。