Clinical trial of an innovative digital therapeutic for smoking cessation with biochemical verification

具有生化验证的创新数字戒烟疗法的临床试验

• 批准号: 9557379
• 负责人: Brian Iacoviello
• 金额: $ 22.5万
• 依托单位: CLICK THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9557379
• 关键词: Abstinence; Address; Adverse effects; Advertisements; Back; Behavior Therapy; Behavioral; Biochemical; Blinded; Breathing; Caring; Cause of Death; Cessation of life; Cigarette; Client; Clinical; Clinical Practice Guideline; Clinical Trials; Counseling; Data; Development; Employee Assistance Program (Health Care); Enrollment; Exposure to; Goals; Gold; Health; Health Care Costs; Health Personnel; Healthcare; Internet; Intervention; Knowledge; Medicaid; Medical; Methodology; Methods; National Cancer Institute; New York City; Participant; Patients; Penetration; Performance; Persons; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Phase; Population; Prevalence; Public Health; Publishing; Randomized Controlled Trials; Research; Research Support; Resources; Risk; Safety; Sales; Sample Size; Self-Direction; Small Business Innovation Research Grant; Smoker; Smoking; Subgroup; Target Populations; Testing; Text Messaging; Therapeutic; Time; United States; arm; barrier to care; base; behavioral health; behavioral outcome; cigarette smoking; clinical practice; commercial application; commercialization; comparative efficacy; cost; design; digital; effective therapy; efficacy trial; financial incentive; follow-up; handheld mobile device; health care availability; health plan; improved; innovation; literacy; mHealth; member; nicotine replacement; payment; personalized intervention; phase 1 study; phase 2 study; population based; programs; recruit; smartphone Application; smoking cessation; social engagement; standard measure; standard of care; technological innovation; treatment adherence; trial comparing

Cigarette smoking is the leading preventable cause of death in the US. Although 7 out of 10 smokers want to quit, less than 5% of quit attempts remain successful one year later. Smartphone apps are a promising method to deliver behavioral interventions due to their immediate accessibility, reduced barriers to treatment, and high penetration of the target population. The goal of this SBIR is to reduce the health impact of smoking by establishing Click Therapeutics, Inc.’s smartphone app for smoking cessation, Clickotine® (CKT), as a digital therapeutic solution to help smokers quit with lower cost, reduced need for healthcare access, and fewer adverse effects than current best alternatives. CKT follows US Clinical Practice Guidelines (USCPG) for smoking cessation and uses interventions supported by research: personalized messaging, controlled breathing, social engagement, treatment adherence, financial incentives, and digital diversions. Short-term quit rates observed in a pilot clinical trial of CKT compare favorably to published results of other smartphone apps for smoking cessation. However, to date no such studies have provided biochemically verified evidence for long-term quit rates, which forms the gold standard for measuring other therapies for smoking. This project will address this gap in knowledge through blinded randomized controlled trials comparing CKT to another widely used USCPG smartphone app, the National Cancer Institute’s QuitGuide. This pivotal research will feature longer-term follow-up and biochemical verification with feasibility established in Phase I. The results of this study will provide the rigorous clinical evidence for the efficacy and safety of CKT necessary for its successful commercialization in the digital therapeutics market. Wide availability of an engaging, low-cost mobile intervention to help smokers quit with reduced healthcare usage will have substantial population-level impact on public health in the United States.

尽管吸烟是美国可预防的主要死因 7。 十分之一的吸烟者想要戒烟，只有不到 5% 的戒烟尝试仍然成功 一年后，智能手机应用程序是一种很有前途的提供行为的方法。 干预措施因其直接可及性、减少治疗障碍、 SBIR 的目标是减少目标人群的渗透率。 通过建立 Click Therapeutics, Inc. 的智能手机应用程序来了解吸烟对健康的影响 对于戒烟，Clickotine® (CKT) 作为数字治疗解决方案可以帮助 吸烟者戒烟的成本更低，对医疗保健的需求减少，戒烟人数也更少。 与目前最佳替代方案相比，CKT 的不良反应遵循美国临床实践。 戒烟指南 (USCPG) 和使用干预措施支持 研究：个性化消息传递、控制呼吸、社交参与、 治疗依从性、经济激励和短期戒烟。 CKT 试点临床试验中观察到的比率优于已发表的结果 然而，迄今为止还没有此类研究。 提供了长期戒烟率的生化验证证据，形成 该项目将成为衡量其他吸烟疗法的黄金标准。 通过盲法随机试验弥补这一知识差距 将 CKT 与另一个广泛使用的 USCPG 智能手机应用程序 National Cancer 进行比较 该研究所的戒烟指南将进行长期跟踪和研究。 第一阶段的生化验证具有可行性。 研究将为CKT的有效性和安全性提供严格的临床证据 这是其在数字治疗市场成功商业化所必需的。 广泛提供有吸引力的、低成本的移动干预措施来帮助吸烟者戒烟 随着医疗保健使用量的减少将对人口层面产生重大影响 美国的公共卫生。