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: 10794665
• 负责人: Charles Chiedu Nwaokobia
• 金额: $ 131.88万
• 依托单位: EVON MEDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10794665
• 关键词: Development; Evaluation; Enhanced; Digital; Chemosensory

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.

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、适应文化的数字化平台 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，以及跑步和跑步的应用 解释干预措施和感官获取计划；(2) 面向提供者的门户网站，用于 社会弱势群体和性少数人群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 COVID-19 大流行的优先性提高了以患者为中心的 SUD 远程管理的需求。 虽然数字疗法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社区 由于无法阅读、数字文盲、无法访问这些移动平台，人们在采用这些移动平台方面滞后 智能手机、缺乏可靠的 Wi-Fi 或互联网以及财务限制。 存在针对阿片类药物使用障碍 (OUD) 的药物，但没有针对可卡因或兴奋剂使用障碍的药物。 存在 OUD 的 AA 和 HA 社区，尤其是男男性行为者 (MSM) 的社区，拥有更多 严重并存的可卡因、甲基苯丙胺和酒精使用障碍以及这些疾病的数字解决方案； 另一方面，人口缺乏提供者，缺乏适应性强、基于智能的生理和能力。 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感应的眶额 阿片类药物使用障碍 (CBOT) 的皮层训练 基于 CBOT 对我们社交的限制。 针对弱势 AA、HA 和 MSM 人群，我们最近修订了治疗兴奋剂和 酒精使用障碍，通过包括β-石竹烯化学感应刺激我们建议进一步的产品。 开发，对面向患者的平台进行创新性改变，并建立一个新的面向提供商的平台 指导 OUD、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，我们将在第一阶段配置面向患者的平台： 语音。 不同语言的命令，特别适合非英语、非 Wi-Fi 或依赖互联网的用户 连接解决方​​案和可靠的瞳孔、脉搏率、其他生理和心理（例如渴望） 采集；以及面向提供商的组件，以 HIPAA 安全方式提供患者数据的解释 我们将在附属的物质使用社区计划和社区中进行初步测试。 在第二阶段，我们将针对华盛顿特区和马里兰州服务不足的社区的人口开展一项活动。 EDITOR 与常规治疗和 CBOT 治疗进行比较的试点随机试验 与 Evon Medics 和霍华德大学相关的多个联邦资助项目中的 SUD。 I 期和 II 期完成后，我们将准备将研究扩展到更大的 III 期疗效 研究，或通过商业伙伴关系研究现实世界中的有效性 据我们所知，这将是在该项目过程中开发的首次评估。 基于数字化学感应的 SUD 远程管理平台，在文化上适应社会 弱势社区和人群。