Hale: A Mobile-Connected Medical Vaporizer that Alleviates Nicotine Dependence

Hale：一款可减轻尼古丁依赖的移动连接医疗蒸发器

• 批准号: 10740808
• 负责人: Joshua Israel
• 金额: $ 5.47万
• 依托单位: HAVA HEALTH INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-09 至 2023-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10740808
• 关键词: Address; Adult; Aerosols; Authorization documentation; Back; Behavioral; Blood; Cardiovascular Diseases; Chronic; Cigarette; Clinical; Combined Modality Therapy; Complex; Custom; Data; Development; Device Safety; Devices; Dose; Effectiveness; Electronic Nicotine Delivery Systems; Electronics; Exposure to; Formulation; Goals; Health; Inhalation Toxicology; Intake; Manuals; Medical; Modeling; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Nose; Patients; Performance; Pharmacologic Substance; Phase; Public Health; Rattus; Safety; Smoke; Smoker; Smoking; Specific qualifier value; Structure of parenchyma of lung; System; Telephone; Testing; Time; Tissues; Translating; Vaporizer; Withdrawal Symptom; addiction; aerosolized; authority; cancer risk; cigarette smoking; clinically relevant; combat; electronic cigarette use; improved; in vivo; innovation; nicotine replacement; performance tests; prototype; safety testing; smoking cessation; smoking-related disease; vapor

PROJECT SUMMARY Cigarette smoking is a significant public health concern impacting 34 million adults in the USA by increasing their risk for cancer and cardiovascular disease, including 16 million living with chronic smoking-related diseases. National campaigns for smoking cessation have been promoted by public authorities, and other groups. In addition, pharmaceutical-grade nicotine replacement therapy (NRT) products have been developed to assist with cessation (gums, lozenges, patches, etc.). Sadly, current standard NRT dosing is not effective for many smokers since nicotine is provided at much lower doses than cigarettes. Many smokers switched to using e-cigarettes (ECs) with cartridges (electronic nicotine delivery systems or ENDS). ENDS closely mimic the act of smoking and provide rapid nicotine dosing that can be scaled back manually. Recent studies have shown limited effectiveness data in support of the continued use of EC in smoking cessation plans, but more data are needed. Hence, effectiveness must still be improved for NRTs since addiction is complex, and current NRTs lack similar nicotine dosing and sensorimotor mimicking compared to smoking cigarettes. This highlights a significant, unmet clinical need for an NRT combining the behavioral aspects of smoking with automated nicotine dosing. Hava Health Inc. leverages these behavioral aspects with flavorless formulations and automated, gradual nicotine reduction controlled by an app to improve smoking cessation. Therefore, the goal of this Phase I project is the development of Have Health’s Hale Vaporizer System, a proprietary NRT using an automated ENDS including the Hale vapor device, flavorless nicotine formulations, and a phone app that automatically lowers nicotine intake gradually over time. For Specific Aim 1, testing will be conducted of the Hale vaporizer’s performance and aerosol safety profile with a finished version of the device. This will include device safety testing in aerosolizing custom nicotine and non-nicotine formulations. In Specific Aim 2, a limited in vivo dose-range finding study to translate former findings to a more clinically relevant model. Studies will be initiated in rats introduced to aerosol via smoke machines, in a repeat dose nose-only inhalation toxicology study. At specified time points post exposure to vapor, we propose collecting and testing: a) blood for nicotine concentration b) lung tissue for toxic or tissue specific effects. To our knowledge, no commercially available NRT is available using flavorless nicotine formulations and an automated electronic delivery system that is not manually adjusted by the patient. The proposed studies are necessary for further development of the Hale Vaporizer System into a best-in-class NRT to help improve compliance by aiding smokers along the path to smoking cessation in a timely manner.

项目概要 吸烟是一个重大的公共卫生问题，影响着美国 3400 万成年人，增加了他们的吸烟率。 癌症和心血管疾病的风险，其中包括 1600 万人患有慢性吸烟相关疾病。 公共当局和其他团体一直在推动全国戒烟运动。 此外，还开发了药物级尼古丁替代疗法 (NRT) 产品来协助 戒烟（口香糖、含片、贴片等）可悲的是，目前的标准 NRT 剂量对许多吸烟者来说并不有效。 由于尼古丁的含量比香烟低得多，许多吸烟者转而使用电子烟。 带有烟弹（电子尼古丁输送系统或 ENDS）的电子烟（EC）与吸烟行为非常相似。 并提供可手动缩减的快速尼古丁剂量，最近的研究显示其局限性。 支持在戒烟计划中继续使用 EC 的有效性数据，但需要更多数据。 因此，NRT 的有效性仍需提高，因为成瘾很复杂，并且当前的 NRT 缺乏类似的 与吸烟相比，尼古丁剂量和感觉运动模仿这突出了一个重要的、 将吸烟行为方面与自动尼古丁相结合的 NRT 的临床需求尚未得到满足 Hava Health Inc. 通过无味配方和自动化来利用这些行为方面， 通过应用程序控制逐渐减少尼古丁以改善戒烟。 第一阶段项目是开发 Have Health 的 Hale Vaporizer 系统，这是一种专有的 NRT，使用 自动化 ENDS 包括 Hale 蒸汽装置、无味尼古丁配方和手机应用程序 随着时间的推移自动逐渐降低尼古丁摄入量 对于特定目标 1，将进行测试。 Hale 蒸发器的性能和气溶胶安全性以及该设备的成品版本将包括在内。 在特定目标 2 中，雾化定制尼古丁和非尼古丁配方的设备安全性测试。 将以前的研究结果转化为更具有临床相关性的模型的体内剂量范围研究将是。 在一项重复剂量仅鼻吸入毒理学研究中，在通过烟雾机引入气溶胶的大鼠中启动。 在暴露于蒸气后的指定时间点，我们建议收集并测试： a) 血液中的尼古丁 b) 肺组织的毒性或组织特异性作用 据我们所知，没有市售的 NRT。 可使用无味尼古丁配方和自动电子传输系统，该系统不是 所提出的研究对于 Hale 的进一步发展是必要的。 将汽化器系统融入一流的 NRT 中，通过帮助吸烟者戒掉烟瘾来帮助提高依从性 及时戒烟。