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; 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.

抽象的 增强基于数字化学化学的嗅觉培训的开发和评估 物质使用障碍（编辑）的远程管理是一个开发可持续，可扩展性的项目 和以患者为中心的移动健康平台，包括（1）面向患者的文化适应性数字 用于刺激性，酒精和阿片类药物使用障碍的化学感应疗法，获取客观的传感器 物质中毒和提取物质的物理措施，以及用于跑步的应用 解释干预措施和感官获取计划； （2）面向提供商的Web门户网站 在社会养育和性少数群体中，药物使用障碍治疗。管理 药物使用障碍（SUD）主要涉及患者与提供者之间的直接接触，但是 COVID-19的优先次数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为远程管理提供了途径，但我们 非洲裔美国人（AA），西班牙裔美国人（HA）和其他处于弱势群体的社区 由于无法阅读，数字文盲，无法访问这些移动平台，种群滞后于采用这些移动平台 智能手机，没有可靠的Wi-Fi或Internet以及财务限制。而且，干预措施 存在阿片类药物使用障碍（OUD），没有可卡因或兴奋剂使用障碍的药物。服务不足 AA和HA社区与Oud，尤其是与男人发生性关系的边缘化男人（MSM）有更多 严重的共存可卡因，甲基苯丙胺和酒精使用障碍；和这些用于这些的数字解决方案 人口缺乏。另一方面，提供者缺乏适应性良好，基于智能的生理学和 心理物理采集平台指导阿片类药物和饮酒的远程激动剂管理。 通过第一阶段的SBIR，Evon Medics开发了一个基于数字化学感应的组合轨道轨道 阿片类药物使用障碍的皮质培训（CBOT）。基于CBOT的局限性 不利的AA，HA和MSM人口，我们最近修改了治疗兴奋剂的平台 酒精使用障碍，包括β-蛋黄油化学气化刺激。我们提出了进一步的产品 开发，针对面向患者的平台的创新更改，以及一个面向供应商的新平台 指导OUD，刺激剂（可卡因和甲基苯丙胺）的远程管理和酒精使用障碍 通过快速轨道SBIR资助。在第一阶段，我们将使用以下方式配置面向患者的平台 具有不同语言的命令，特别是对于非英语，非WI-FI或互联网依赖的命令 连接解决方​​案和可靠的瞳孔，脉搏率，其他身体和心理（例如，渴望） 收购；以及面向提供商的组件，以在HIPAA安全中提供患者数据的解释 门户网站。我们将在会员药物使用社区计划和社区中进行初步测试 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 与往常的治疗相比，编辑的飞行员随机试验，用于办公室的治疗 与Evon Medic和Howard University有关的几个联邦资助计划中的SUD。之上 I和II阶段的完成，我们将被毒化以将研究扩展到更大的第三阶段效率 研究或通过商业合作伙伴关系对现实环境中有效性的实施研究 在这个项目的过程中开发。据我们所知，这将是对 基于数字化学化学的SUD管理平台，在文化上适用于社会 处境不利的社区和人口。