Development of a telehealth medication-assisted treatment (MAT) system for patients with opioid use disorder (OUD)

项目摘要 每年都有数百万张阿片类药物处方。2018年，70，237例药物过量死亡中有近70% 在美国，涉及阿片类药物的死亡人数预计到2025年将增加到81，700人。COVID-19疫情 进一步加剧了这一点，并暴露了治疗OUD患者的许多弱点。 疾病控制和预防中心（CDC）的临时数据显示，药物过量死亡 从2019年5月到2020年5月增长了15%以上。在这些处方阿片类药物的患者中， 8-12%的人后来会出现阿片类药物使用障碍（OUD）。鉴于处方阿片类药物仍然是 OUD是通过这些途径开始的，减少其滥用和转移可以随着时间的推移转化为减少死亡。 许多患有OUD的患者通过丁丙诺啡与咨询和行为治疗相结合来治疗。 治疗，也称为药物辅助治疗（MAT）。虽然丁丙诺啡的成瘾性比 阿片类药物或其它治疗（例如，美沙酮），但它并非不会被滥用或转移。因此有 这是开发旨在远程治疗OUD和预防OUD的新技术的重要机会。 药物误用、滥用和转移。虽然几种安全分配器技术正在开发中， 仍然迫切需要一种全面的解决方案，该解决方案预防和/或治疗成瘾，跟踪使用情况， 收集数据，并消除多余的药物，同时还保持模块化和成本效益，足以 广泛使用。Addinex Technologies，Inc.正在开发唯一的解决方案，每名患者不到20美元， 结合：1）专利，安全，低成本和模块化药物分配器，控制药物访问 并鼓励方便和安全地处理未使用的药物，结合2）陪伴移动的患者 应用程序和医生/药剂师基于网络的软件，具有交互式模块和调查，以提高 患者教育和参与、护理人员监测和远程治疗，以促进患者-提供者 交互.在第一阶段SBIR中，Addinex将（目标1）为家庭OUD开发其综合系统 通过修改它以与suboxone条一起使用并增强其配套软件来治疗OUD 处理和文本兼容性。然后，我们将（目标2）利用与耶鲁大学医学院的合作， 家庭成瘾治疗研究所（IHATI）/意识恢复调查治疗提供者，以获得 反馈，将指导Addinex系统整合到OUD治疗计划中，并进行 基于文本和基于应用程序的系统在接受治疗的患者（n = 60）中的可用性和可接受性研究 OUD治疗。这些目标的成功完成将为进一步优化Addinex提供重要的见解 系统，并指导设计一个更大的，随机对照试验，以证明其疗效和成本- 有效性最终，这项研究将成为开发一个具有成本效益的系统的跳板， 广泛使用，用户友好，目的是增加依从性，减少治疗时间， 减少药物滥用，增加治疗保留，减少OUD治疗复发 为许多受苦的人。

PROJECT SUMMARY Millions of opioid prescriptions are written each year. In 2018, nearly 70% of the 70,237 drug overdose deaths in the U.S. involved opioids, a figure that is projected to grow to 81,700 deaths by 2025. The COVID-19 pandemic is further exacerbating this and has exposed many vulnerabilities in the treatment of patients with OUD. Provisional data from the Centers for Disease Control and Prevention (CDC) shows that drug overdose deaths have increased by more than 15% from May 2019 to May 2020. Of those patients prescribed opioids, between 8-12% will later develop opioid use disorder (OUD). Given that prescription opioids remain the dominant route through which OUD begins, reducing their abuse and diversion can translate over time into reduced deaths. Many patients with OUD are treated by a combination of buprenorphine with counseling and behavioral therapies, also known as Medication Assisted Treatment (MAT). Although buprenorphine is less addictive than opioids or other treatments (e.g., methadone), it is not invulnerable to abuse or diversion. There is therefore a significant opportunity for the development of new technologies aimed at remotely treating OUD, and preventing drug misuse, abuse, and diversion. Although several secure dispenser technologies are under development, there remains a critical need for a comprehensive solution that prevents and/or treats addiction, tracks usage, collects data, and eliminates excess medication, while also remaining modular and cost effective enough to be widely accessible. Addinex Technologies, Inc. is developing the only solution that, for less than $20/patient, combines: 1) a patented, secure, low-cost and modular medication-dispenser which controls medication access and encourages convenient and safe unused medication disposal, combined with 2) companion mobile patient app and physician/pharmacist web-based software that features interactive modules and surveys to improve patient education and engagement, caregiver monitoring, and teletherapy to facilitate patient-provider interactions. In this Phase I SBIR, Addinex will (Aim 1) develop their comprehensive system for at-home OUD treatment by modifying it for use with suboxone strips and enhancing their companion software for OUD treatment and text-compatibility. We will then (Aim 2) leverage a collaboration with Yale School of Medicine and the In-Home Addiction Treatment Institute (IHATI)/Aware Recovery to survey treatment providers to obtain feedback that will guide the integration of the Addinex system into OUD treatment programs and conduct a usability and acceptability study for the text-based and app-based system across patients (n = 60) undergoing OUD treatment. Successful completion of these aims will provide critical insights to further optimize the Addinex system and to guide the design of a larger, randomized controlled trial to demonstrate its efficacy and cost- effectiveness. Ultimately, this study will be the springboard for the development of a system that is cost-efficient, widely accessible, and user-friendly, with the aim of increasing adherence, decreasing treatment time, decreasing the misuse of medication, increasing treatment retention, and reducing relapses in OUD treatment for the many who are suffering.