Tailored NRT Integrated with Smartphone Behavioral Support

 描述（由申请人提供）：CDC指出，吸烟导致80%的肺癌和每年443，000例死亡，是美国主要的可预防死亡原因。吸烟者在可预测的时间有高峰渴望，但现有的NRT并不是针对先发制人的渴望而设计的。此外，NRT通常与行为支持隔离使用，尽管数据支持传统和基于移动的干预措施的益处。最后，基于移动的戒烟干预措施需要创新，以提供循证规划，同时产生积极的用户体验和持续利用。 时空治疗公司(CTI)已开发、获得专利并在人类中进行临床测试的SmartStop（TM）（SS或SmartStop）技术，用于戒烟的程序化和患者个性化脉冲尼古丁替代疗法（NRT）。在NCI 223万美元的赠款支持下，CTI正处于开发SS的高级阶段，该SS是一种“智能”可穿戴NRT设备，通过定制NRT来预先阻止吸烟者可预测的渴望模式，从而抵消尼古丁戒断。SS项目的NRT部分由NCI赠款和私人基金资助。在本项目中，CTI将增加（i）通过戒烟移动的应用程序Digital Coach（DC）提供的行为支持组件，（ii）智能手机通信应用程序（SCA），作为SS和后端数据库（将与Digital Coach共享）之间安全数据交换的管道，（iii）内置于SS设备中的无线通信技术，以允许数据传输到移动的组件，以及（iv）SS和DC用于跟踪渴望发作的机制，从而提供更智能、更有针对性的辅导支持。我们的目标也是在SS中添加基于传感器的合规性监控，但不是本提案的一部分。CTI认为，智能NRT、智能行为支持和依从性监测的结合将使戒烟效果提高到32%或更高。 SmartStop是CTI的具有无线通信功能的“智能”NRT设备，将与SCA和DC集成，以提供（i）基于广泛接受的心理学原理并与SS的NRT输送同步的“智能”最佳时间的渴望管理和行为干预，以及（ii）基于传感器的实时依从性监测系统，通过智能手机提供基于算法的，个性化和主动式消息传递，以鼓励正确使用SS设备并遵守SS设备。SS的关键技术和治疗创新是（i）将患者个性化NRT和行为干预（通过配对的智能手机）整合在一起，该行为干预与NRT方案最佳匹配，以及（ii）创建独特的行为支持内容和算法，以确保基于吸烟者的实际NRT使用和报告的渴望模式的同步和互补的可编程NRT和行为支持。

 DESCRIPTION (provided by applicant): The CDC states that smoking causes 80% of lung cancers and 443,000 deaths annually and is the leading preventable cause of death in the USA. Smokers have peak cravings at predictable times, but existing NRTs are not tailored to preempt cravings. Further, NRT is often used in isolation from behavioral support despite data supporting the benefits of traditional and mobile-based interventions. Finally, innovation is needed in mobile-based cessation interventions to deliver evidence-based programming that also generates a positive user experience and ongoing utilization. Chrono Therapeutics, Inc. (CTI) has developed, patented and clinically tested in humans a technology, SmartStop(tm) (SS or SmartStop), for programmed and patient-individualized pulsatile nicotine replacement therapy (NRT) for smoking cessation. With $2.23M in grant support from the NCI, CTI is in the advanced stages of developing SS for manufacture as a `smart' wearable NRT device that counteracts nicotine withdrawal by tailoring NRT to pre-empt smokers' predictable craving patterns. The NRT component of the SS project is funded by the NCI grant and private funds. In this project, CTI will add (i) a behavioral support component via a smoking cessation mobile application, Digital Coach (DC), (ii) a SmartPhone Communication Application (SCA) that serves as the conduit for secure data exchange between SS and a Back End database which will be shared with Digital Coach, (iii) wireless communication technology built into the SS device to allow data transfer to the mobile components and (iv) a mechanism to SS and DC for tracking of craving episodes, allowing smarter more tailored coaching support. It is also our objective, but not part of this proposal, to add sensor-based compliance monitoring to SS. CTI believes that the combination of smart NRT, smart behavioral support and compliance monitoring will increase smoking cessation efficacy to 32% or greater. SmartStop, CTI's `smart' NRT device with wireless communication capability will be integrated with SCA and DC to provide (i) `smart' optimally-timed cravings management and behavioral interventions based on widely accepted psychological principles and synchronized with SS's delivery of NRT and (ii) a real-time sensor-based compliance monitoring system that delivers, via smartphone, algorithm-based, personalized and proactive messaging to encourage proper utilization of, and compliance with, the SS device. The key technical and therapeutic innovations in SS are (i) the integration of patient-individualized NRT and a behavioral intervention (via a paired smartphone) that is optimally timed to the NRT regimen and (ii) the creation of unique behavioral support content and algorithms to ensure synchronized and complementary programmable NRT and behavioral support based on smokers' actual NRT use and reported craving patterns.