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: 10469912
• 负责人: Charles Chiedu Nwaokobia
• 金额: $ 33.07万
• 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/10469912
• 关键词: Abstinence; Address; Adoption; Adult; African American; African American population; Agonist; Alcohol consumption; Alcohol withdrawal syndrome; Alcohols; Animal Model; Behavior; Behavior Therapy; Beta-caryophyllene; COVID-19 pandemic; Cellular Phone; Clinic; Clinical; Cocaine; Cocaine use disorder; Communities; Costs and Benefits; Custom; Data; Defect; Development; Devices; Disadvantaged minority; Dopamine; Dose; Drug Controls; Drug usage; Effectiveness; Emergency Situation; Epidemic; Evaluation; Failure; Feedback; Food; Funding; Future; Health; Health Insurance Portability and Accountability Act; Health Status; Heart Rate; Hispanic Americans; Infrastructure; Instruction; Intake; Intelligence; Internet; Intervention; Intoxication; Language; Link; Machine Learning; Maryland; Measures; Mediating; Methamphetamine use disorder; Midbrain structure; Minority; Minority Groups; Modeling; Monitor; Olfactory Cortex; Opioid; Outcome; Overdose; Patient Transfer; Patients; Pharmaceutical Preparations; Phase; Physicians; Physiological; Pilot Projects; Population; Provider; Psychophysics; Pulse Rates; Records; Relapse; Research; Running; Secure; Sensory; Services; Signs and Symptoms; Site; Skin; Small Business Innovation Research Grant; Social Distance; Social isolation; Social status; Stimulant; Substance Use Disorder; Testing; Text; Therapeutic; Training; Treatment outcome; Universities; Virus Diseases; Visual; Voice; Washington; Withdrawal; active control; alcohol use disorder; artificial intelligence algorithm; base; cloud based; cocaine use; combinatorial; community clinic; comorbidity; computerized; craving; design; digital; digital treatment; disadvantaged population; dosage; effectiveness evaluation; effectiveness implementation study; effectiveness testing; efficacy study; health care service; illiteracy; illiterate; improved; innovation; instrument; mHealth; medically underserved population; medication-assisted treatment; men who have sex with men; methamphetamine use; mobile computing; neuroregulation; non-drug; novel; operation; opioid agonist therapy; opioid use disorder; opioid user; opioid withdrawal; patient oriented; patient population; patient portal; phase III trial; portability; product development; programs; psychologic; randomized trial; remote delivery; remote therapy; sensor; sexual minority group; social disadvantage; stimulant use; stimulant use disorder; substance use; substance use treatment; therapeutic opioid; therapeutically effective; treatment as usual; underserved community; 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) 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.

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，以及用于跑步和 解释干预措施和感觉获得程序;以及（2）面向提供者的门户网站， 在社会弱势群体和性少数群体中进行物质使用障碍治疗。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 2019冠状病毒病疫情的出现提升了对以患者为中心的SUD远程管理的需求。 虽然数字治疗和移动的健康平台为远程管理提供了途径，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 人口在采用这些移动的平台方面滞后，原因是无法阅读、数字文盲、缺乏获得 智能手机，缺乏可靠的Wi-Fi或互联网，以及财务限制。此外，虽然干预措施 目前，阿片类药物使用障碍（OUD）的药物还没有，可卡因或兴奋剂使用障碍的药物还没有。服务不足 患有OUD的AA和HA社区，特别是与男性发生性关系的边缘化男性（MSM）， 严重的可卡因、甲基苯丙胺和酒精使用障碍并存;以及这些问题的数字解决方案 人口缺乏。另一方面，提供者缺乏适应良好的、基于智能的生理和心理能力， 心理物理采集平台，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SBIR，EVON Medics开发了一种基于组合数字化学传感器的眶额 阿片类药物使用障碍（CBOT）的皮质训练。基于CBOT对我国社会的局限性， 我们最近修订了兴奋剂治疗平台， 酒精使用障碍，通过包括β-卡连素化学感觉刺激。我们建议进一步的产品 开发，对面向患者的平台进行了创新性更改，并推出了一个新的面向提供者的平台， 指导远程管理OUD、兴奋剂（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融资。在第一阶段，我们将为面向患者的平台配置： 不同语言的命令，特别是对于非英语，非Wi-Fi或互联网依赖 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） 和面向提供者的组件，以在HIPAA-secure中提供对患者数据的解释。 portal.我们将在附属的物质使用社区项目和社区中进行初步测试 在华盛顿，DC和马里兰州服务不足的社区的人口。在第二阶段，我们将执行 EDITOR与常规治疗和CBOT在基于诊所的治疗中的比较的初步随机试验 在与Evon Medics和霍华德大学相关的几个联邦资助项目中的SUD。后 完成第一阶段和第二阶段，我们将准备扩大研究，要么更大，第三阶段的疗效 研究，或通过商业伙伴关系在现实世界环境中的有效性实施研究 在这个项目的过程中发展起来。据我们所知，这将是第一次评估 基于数字化学传感器的SUD远程管理平台，在文化上适应社会 弱势群体和人口。