mHealth for Patient Self-Management of Opioid Use Disorder - Administrative Supplement

项目摘要/摘要 阿片类药物危机是一种流行病，对健康、社会和经济造成毁灭性后果 美国。从1999年到2018年，近45万人死于阿片类药物过量， 包括处方和非法阿片类药物。三百万美国公民和全球一千六百万个人 曾经或目前患有阿片类药物使用障碍(OUD)。阿片类药物的总经济负担 据估计，美国每年的危机规模超过2000亿美元。 OUD的治疗包括药物辅助治疗(MAT)结合咨询或 行为疗法，以控制疾病，实现和维持更好的健康，并提高生活质量。 反复吸毒率很高，获得咨询的机会有限且成本高昂。而马特则是 护理标准和在减少急性发病率和死亡率方面非常有效，有以下优势 针对个别患者的药物使用模式和与药物有关的问题量身定做的治疗方法 医疗、精神和社会问题。虽然存在移动工具来支持OUD治疗，但这些 产品只提供概括的信息，而不提供针对每个产品的个性化反馈 个人的当前状态，以支持其个人康复。 在第一阶段，我们开发了KiOS，这是一个使用非线性控制理论的创新软件平台。 Kios跟踪多个相互作用的症状(例如，渴望、情绪、疼痛)，以绘制患者轨迹和 提供及时的循证干预策略，直接响应患者报告的需求。 Kios可通过移动设备访问，按需为患者提供个性化建议和 加强生活方式干预，提高自我管理水平。第一阶段测试 显著降低了OUD的关键症状以及高参与度、可用性 和病人的满意度。 在第二阶段的研究中，我们正在评估Kios作为一种适合于 等待FDA批准，同时进行MAT治疗。第二阶段研究包含一个为期12周的随机试验 旨在满足获得FDA 510(K)批准的要求的对照试验。与以下项目通信 FDA已经扩大了临床试验的范围，现在包括一个虚假的应用程序，作为Kios的比较器。 这一出人意料的临床试验增加导致了这项行政补充申请的提交 开发和测试Sham应用程序，用于随机对照试验。

PROJECT SUMMARY / ABSTRACT The opioid crisis is an epidemic with devastating health, social, and economic consequences for the United States. From 1999–2018, almost 450,000 people died from an overdose involving an opioid, including prescription and illicit opioids. Three million US citizens and 16 million individuals worldwide have had or currently suffer from opioid use disorder (OUD). The total economic burden of the opioid crisis in the US is estimated to be more than $200 billion annually. Treatment for OUD involves medication assisted treatment (MAT) combined with counseling or behavioral therapy to manage the illness, achieve and sustain better health, and improve quality of life. Rates of recurrent drug use are high, and access to counseling is limited and costly. While MAT is standard of care and highly effective at reducing acute morbidity and mortality, there are advantages to treatment approaches tailored to address an individual patient’s drug use patterns and drug-related medical, psychiatric, and social problems. While mobile tools exist to support OUD treatment, these products offer only generalized information and not personalized feedback that is responsive to each person’s current status to support their individual recovery. In Phase I, we developed KIOS, an innovative software platform using nonlinear control theory. KIOS tracks multiple interacting symptoms (e.g., craving, mood, pain) to map patient trajectories and deliver timely evidence-based intervention strategies, responding directly to patient-reported needs. Accessible via mobile devices, KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during MAT. Phase I beta testing demonstrated significant reductions in key symptoms of OUD and high levels of engagement, usability and patient satisfaction. In Phase II studies, we are evaluating KIOS as a prescription digital health therapeutic suitable for FDA approval concomitant to MAT to treat OUD. The Phase II study contains a 12-week randomized controlled trial designed to satisfy requirements to receive FDA 510(k) clearance. Correspondence with the FDA has led to an expansion of the clinical trial to now include a sham app as a comparator to KIOS. This unexpected addition to the clinical trial has led to the filing of this administrative supplement to develop and test the sham app for use in a randomized controlled trial.