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

项目总结/摘要 阿片类药物危机是一种流行病，对健康，社会和经济造成破坏性后果， 美国的从1999年到2018年，近45万人死于阿片类药物过量， 包括处方药和非法阿片类药物。300万美国公民和全球1600万个人 患有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，以管理疾病，实现和维持更好的健康，并提高生活质量。 吸毒的复发率很高，获得咨询的机会有限，而且费用昂贵。虽然MAT 标准的护理和高度有效地降低急性发病率和死亡率， 针对个体患者的药物使用模式和药物相关的 医学精神和社会问题虽然存在移动的工具来支持OUD治疗，但是这些 产品只提供一般化的信息，而不是对每个人都做出响应的个性化反馈。 个人的现状，以支持他们的个人恢复。 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）来绘制患者轨迹， 提供及时的循证干预策略，直接响应患者报告的需求。 通过移动的设备，KIOS可为患者提供个性化的建议， 加强生活方式干预，以改善MAT期间的自我管理。第一阶段beta测试 OUD的主要症状显著减少，参与度、可用性 患者满意度。 在第二阶段的研究中，我们正在评估KIOS作为一种处方数字健康治疗， FDA批准与MAT一起治疗OUD。II期研究包括一项为期12周的随机 对照试验旨在满足获得FDA 510（k）许可的要求。对应于 FDA已经扩大了临床试验，现在包括一个假应用程序作为KIOS的比较。 临床试验的这一意外增加导致提交了本行政补充文件， 开发并测试用于随机对照试验的假应用程序。

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.