Tailored NRT Integrated with Smartphone Behavioral Support

 描述(由申请人提供)：美国疾病控制与预防中心表示，吸烟每年导致80%的肺癌和443,000人死亡，是美国主要的可预防死亡原因。吸烟者在可预测的时间有烟瘾高峰期，但现有的NRT并不是为先发制人而量身定做的。此外，NRT经常与行为支持分开使用，尽管数据支持传统和基于移动的干预的好处。最后，需要在基于移动的戒烟干预方面进行创新，以提供基于证据的编程，同时产生积极的用户体验和持续的使用。计时治疗公司(CTI)开发了一项技术SmartStop(Tm)(SS或SmartStop)，为戒烟的程序化和患者个性化脉动尼古丁替代疗法(NRT)开发了一项技术，获得了专利并在人体上进行了临床测试。CTI从NCI获得了223万美元的赠款支持，目前正处于开发SS的后期阶段，该设备将被制造为一种“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的影响。SS项目的NRT部分由NCI赠款和私人资金提供资金。在这个项目中，CTI将增加(I)通过戒烟移动应用程序Digital Coach(DC)提供行为支持的组件，(Ii)智能手机通信应用程序(SCA)作为SS和后端数据库之间安全数据交换的通道，该数据库将与Digital Coach共享，(Iii)SS设备中内置的无线通信技术，允许将数据传输到移动组件，以及(Iv)SS和DC跟踪渴望发作的机制，从而实现更智能、更量身定制的指导支持。这也是我们的目标，但不是本提案的一部分，将基于传感器的合规性监控添加到SS中。CTI认为，将智能NRT、智能行为支持和遵从性监测相结合，将把戒烟效果提高到32%或更高。SmartStop，CTI具有无线通信能力的“智能”NRT设备将与SCA和DC集成，以提供(I)基于被广泛接受的心理学原理并与SS的NRT交付同步的“智能”最佳时机的渴求管理和行为干预，以及(Ii)基于传感器的实时合规监控系统，该系统通过智能手机提供基于算法的个性化和前瞻性消息传递，以鼓励正确使用和遵守SS设备。SS的关键技术和治疗创新是(I)将患者个性化的NRT与行为干预(通过配对的智能手机)相结合，这是NRT方案的最佳时机，以及(Ii)创建独特的行为支持内容和算法，以确保基于吸烟者实际NRT的使用和报告的渴求模式，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.