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，影响了美国的3400万成年人。 患癌症和心血管疾病的风险，包括1600万人患有与慢性吸烟有关的疾病。 公共当局和其他团体已经促进了全国性戒烟的运动。在 此外，已经开发了药物级尼古丁替代疗法（NRT）产品来协助 戒烟（牙龈，烤斑，补丁等）。可悲的是，当前的标准NRT剂量对许多吸烟者无效 由于尼古丁的剂量比香烟低得多。许多吸烟者转向使用电子烟 （ECS）带有墨盒（电子尼古丁输送系统或末端）。结束紧密模仿吸烟的行为 并提供可以手动缩放的尼古丁剂量。最近的研究表明有限 有效性数据支持继续在戒烟计划中继续使用EC，但需要更多数据。 因此，由于成瘾很复杂，因此必须提高NRT的有效性，并且当前的NRT缺乏相似的 与吸烟相比，尼古丁的剂量和感觉运动模仿。这突出了一个重要的 未满足的NRT临床需求将吸烟与自动尼古丁的行为方面结合在一起 给药。 Hava Health Inc.通过无味的公式和自动化来利用这些行为方面 逐渐减少的尼古丁降低由应用程序控制，以改善戒烟。因此，目标的目标 第一阶段项目是Health的Hale蒸发器系统的开发，这是一种专有的NRT 自动末端，包括Hale Vapor设备，无味的尼古丁配方和手机应用程序 随着时间的流逝，自动降低尼古丁摄入量。对于特定目标1，将进行测试 Hale Vaporizer的性能和带有该设备的成品版本的气溶胶安全性。这将包括 在雾化自定义尼古丁和非雪Nicotine公式中进行的设备安全测试。在特定目标2中，有限 体内剂量范围的发现研究将以前的发现转化为更临床相关的模型。研究将是 在通过烟雾机引入气溶胶的大鼠中，在仅剂量鼻子毒理学研究中启动。 在暴露于蒸气后指定的时间点，我们提出收集和测试：a）尼古丁的血液 浓度b）肺组织有毒或组织特异性作用。据我们所知，没有市售的NRT 使用无味的尼古丁公式和一个不是自动化的电子传递系统 由患者手动调整。拟议的研究对于进一步开发Hale是必要的 蒸发器系统进入一流的NRT，以通过沿着通往的道路帮助吸烟者来帮助提高合规性 及时戒烟。