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.

项目摘要 吸烟是一个重大的公共卫生问题，影响着美国3400万成年人， 癌症和心血管疾病的风险，包括1600万患有慢性吸烟相关疾病的人。 公共当局和其他团体推动了全国戒烟运动。在 此外，还开发了药物级尼古丁替代疗法（NRT）产品，以帮助 戒烟（口香糖、锭剂、贴剂等）。可悲的是，目前的标准NRT剂量对许多吸烟者无效 因为尼古丁以比香烟低得多的剂量提供。许多吸烟者转而使用电子烟 (ECs)电子尼古丁输送系统（Electronic Nicotine Delivery Systems，ENDS）末端与吸烟的行为非常相似 并提供可手动缩减的快速尼古丁剂量。最近的研究表明， 有效性数据支持在戒烟计划中继续使用EC，但需要更多数据。 因此，NRT的有效性仍需提高，因为成瘾是复杂的，目前的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， 未满足的NRT临床需求，将吸烟的行为方面与自动尼古丁结合起来 剂量。Hava Health Inc.利用这些行为方面的无味配方和自动化， 通过应用程序控制逐渐减少尼古丁，以改善戒烟效果。因此，这一目标 第一阶段项目是开发Have Health的黑尔蒸发器系统，这是一种专有的NRT， 包括黑尔蒸汽装置、无味尼古丁配方和 随着时间的推移自动降低尼古丁的摄入量。对于具体目标1，将对 黑尔蒸发器的性能和气雾剂安全性特征以及该器械的成品版本。这将包括 雾化定制尼古丁和非尼古丁制剂的设备安全性测试。在具体目标2中， 体内剂量范围探索研究，将先前的发现转化为更具临床相关性的模型。研究将 在一项重复剂量仅经鼻吸入毒理学研究中，通过烟雾机将大鼠吸入气雾剂。 在暴露于蒸汽后的特定时间点，我们建议收集和测试：a）尼古丁的血液 浓度B）肺组织的毒性或组织特异性效应。据我们所知，没有市售NRT 使用无味的尼古丁配方和自动电子输送系统， 由患者手动调节。拟议的研究对于黑尔的进一步开发是必要的 汽化器系统转换为一流的NRT，通过帮助吸烟者沿着 及时戒烟。