Assessing the effect of nicotine reduction on ENDS user's addiction and exposures

评估减少尼古丁对电子尼古丁传送系统使用者成瘾和接触的影响

• 批准号: 10351405
• 负责人: Wasim Maziak
• 金额: $ 40.22万
• 依托单位: FLORIDA INTERNATIONAL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10351405
• 关键词: Abstinence; Acute; Address; Aerosols; Affect; Aldehydes; Behavior; Brain; Characteristics; Cigarette; Cigarette Smoker; Clinical; Clinical Trials; Country; Dependence; Diffuse; Dose; Electronic Nicotine Delivery Systems; Electronic cigarette; Emerging Tobacco Products; Epidemic; Exposure to; Eye; Financial compensation; Formulation; Frequencies; Future; Generations; Goals; Hour; Intake; Intention; JUUL; Liquid substance; Lung; Lung diseases; Measures; Methods; Nausea; Nicotine; Nicotine Dependence; Observational Study; Outcome; Oxygen saturation measurement; Palpitations; Participant; Pattern; Plasma; Poison; Protocols documentation; Pulmonary Function Test/Forced Expiratory Volume 1; Regulation; Reporting; Risk; Robot; Role; Salts; Smoke; Smoker; Smoking; Standardization; Symptoms; Time; Tobacco use; Toxicant exposure; United States; United States Food and Drug Administration; Withdrawal; Xerostomia; Youth; addiction; cigarette smoking; clinical effect; craving; epidemiology study; follow-up; irritation; liquid nicotine; low nicotine content cigarette; nicotine exposure; nicotine use; preference; public health relevance; pulmonary function; recruit; respiratory; response; satisfaction; side effect; smoking initiation; tobacco products; toxicant; trend; vapor

PROJECT SUMMARY The use of electronic nicotine delivery systems (ENDS or e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS emit toxic substances, including nicotine that irreversibly affects the developing brain and leads to dependence and increased risk of cigarette smoking initiation. Evidence indicates that young people using ENDS are likely to accelerate use and become nicotine dependent. Some of the most popular ENDS among youth (e.g. JUUL with 5% nicotine liquid) deliver in one cartridge a nicotine dose equal to an entire pack of cigarettes, and many users are unaware of this substantial exposure and the related risk of addiction. On the other hand, nicotine reduction (NR) has been considered by the US Food and Drug Administration (FDA) as an important strategy to limit the addictiveness and use of tobacco products. Now that the FDA regulates ENDS under the “deeming rule”, such a strategy can be considered for these emerging tobacco products. However, we still lack evidence on the expected effects of a range of NR levels on ENDS users at different stages of use trajectory. Using clinical and analytical lab methods we plan to compare among 5% nicotine ENDS users the effect of partial (3%) or total (nicotine-free, 0%) NR on users' dependence, satisfaction, clinical (e.g. BP, oximetry, lung functions, symptoms), puffing behavior, and exposure to toxicants. We will recruit current ENDS users (n=120; 21-35 yrs), for a 3X2X2 within-between subject crossover lab study. Because the effect of NR on ENDS users will likely vary by frequency and stage of ENDS use, we will study NR effects in high vs. low-frequency users (use on ≥ 20 vs. < 20 days/past month). Therefore, the 3 nicotine conditions (5%, 3%, 0%) x 2 times (pre-post) are the within-subject factors, while the frequency of use is the between-subject factor. We hypothesize that NR will be associated with less satisfaction, withdrawal suppression, and intention to use and that such an effect will be more pronounced in total compared to partial NR and among high compared to low-frequency users. The proposed studies aim to answer 3 main regulatory questions: 1) is NR a promising regulatory option to reduce ENDS addictiveness and use; 2) what is the effect of partial vs. total NR on compensatory puffing and exposure to nicotine and respiratory toxicants, and 3) what is the effect of NR on ENDS users at different stages of their use. Combined, these studies will give direct and standardized evidence on the potential of NR regulations to limit the addictiveness and use of ENDS, and to help predict any potential side effects of NR on ENDS users' exposure to harmful toxicants.

项目总结 电子尼古丁输送系统(电子烟或电子烟)的使用已达到#年的流行水平。 美国的年轻人。烟头会释放有毒物质，包括尼古丁，它会不可逆转地影响 并导致对吸烟的依赖和吸烟风险的增加。证据 表明使用END的年轻人可能会加速使用，并对尼古丁产生依赖。其中一些 最受年轻人欢迎的烟头(例如，含有5%尼古丁液体的Juul)一盒装一盒尼古丁 相当于一整包香烟的剂量，许多使用者并没有意识到这种实质性的接触和 与上瘾相关的风险。另一方面，减少尼古丁(NR)已被美国食品和药物管理局考虑 美国食品药品监督管理局(FDA)将其作为限制烟草产品成瘾性和使用的重要战略。 既然fda在《推定规则》下对末端进行了管制，那么可以考虑对这些末端采取这样的策略。 新兴烟草产品。然而，我们仍然缺乏证据表明一系列天然氮水平对 处于不同使用轨迹阶段的终端用户。使用临床和分析实验室方法，我们计划比较 在5%的尼古丁终端使用者中，部分(3%)或全部(无尼古丁，0%)NR对使用者依赖的影响， 满意度、临床(如血压、血氧、肺功能、症状)、喘气行为和接触毒物。 我们将招募当前最终用户(n=120；21-35年)，进行3X2X2学科间交叉实验 学习。由于NR对终端用户的影响可能会因终端使用的频率和阶段而有所不同，我们将 研究高频率用户和低频率用户的NR效果(过去一个月使用≥20天与20天/月)。因此，这3位 尼古丁条件(5%、3%、0%)x 2次(事后)是受试者内的因素，而使用频率 是主体之间的因素。我们假设NR与较低的满意度、退缩有关 压制和使用意图，而且这种效果总体上比部分效果更明显 与低频度用户相比，高频度用户和高频度用户之间存在较大差异。拟议的研究旨在回答3个主要的监管问题 问题：1)NR是一种有希望的监管选择，以减少末端成瘾性和使用；2)效果是什么 部分NR与完全NR在代偿性吸烟和暴露于尼古丁和呼吸道毒物方面的差异，以及3)什么 是NR对终端用户在其使用的不同阶段的影响。综合起来，这些研究将给出直接和 关于NR法规限制末端成瘾性和使用的潜力的标准化证据，以及 帮助预测天然橡胶对终端用户接触有害毒物的任何潜在副作用。