评估尼古丁减少对 ENDS 用户成瘾和暴露的影响
2026年8月10日 更新者：Florida International University
美国年轻人使用电子尼古丁传送系统 (ENDS) 的人数迅速增加，它们可能危害健康、导致成瘾，并成为吸烟或双重使用的风险，这令人担忧。
ENDS 在美国年轻人中的流行与 ENDS 产品的普及有关，这些产品可以非常有效地向用户提供高剂量的尼古丁。
因此，研究人员建议研究减少尼古丁 (NR) 对年轻 ENDS 使用者的影响，作为降低 ENDS 成瘾性和使用的潜在监管策略。
拟议的研究直接响应 FDA 确定的研究重点，并在本 RFA 的成瘾项下指定；研究“烟草产品特性变化的影响（例如
尼古丁配方）依赖”。
该项目旨在概述该项目的基本原理意义，分为 1) 科学原理和监管影响； 2) 需要应对美国年轻人使用 ENDS 的上升趋势； 3) 降低 ENDS 成瘾性的重要性； 4) 我们用于监管目的的临床和分析实验室方法的优势；和 5) 先前关于用于 ENDS 的 NR 研究的严谨性的优缺点。
研究概览
地位
完全的
条件
详细说明
在美国 (US)，电子尼古丁传送系统（ENDS 或电子烟）的使用在年轻人中已达到流行水平。 ENDS 释放有毒物质，包括尼古丁，它不可逆转地影响发育中的大脑并导致依赖性和增加开始吸烟的风险。 有证据表明，使用 ENDS 的年轻人可能会加速使用并变得对尼古丁产生依赖。 一些最受年轻人欢迎的 ENDS（例如 含有 5% 尼古丁液体的 JUUL）在一个烟弹中提供相当于一整包香烟的尼古丁剂量，许多用户并没有意识到这种大量接触和相关的成瘾风险。 另一方面，减少尼古丁含量（NR）已被美国食品和药物管理局（FDA）视为限制烟草制品成瘾性和使用的重要策略。
既然 FDA 在“推定规则”下对 ENDS 进行监管，那么对于这些新兴的烟草产品，可以考虑采用这样的策略。 然而，研究人员仍然缺乏关于一系列 NR 水平对 ENDS 用户在不同使用轨迹阶段的预期影响的证据。 使用临床和分析实验室方法，研究人员计划在 5% 尼古丁 ENDS 用户中比较部分（3%）或全部（无尼古丁，0%）NR 对用户依赖性、满意度、临床（例如 血压、血氧饱和度、肺功能、症状）、吸气行为和接触有毒物质。 研究人员将招募当前的 ENDS 用户（n=120；21-35 岁），进行 2X2 主题交叉实验室研究。 尼古丁条件 (5%, 3%) 或 (0%, 5%) x 2 次（前后）是受试者内因素。
因此，该研究分为两部分，第一部分将 2x2 比较 NJOY 5% 和 3% 以测试部分尼古丁减少的效果，第二部分将使用 NIDA 标准化研究电子烟 (SREC)临床研究 5% 和 0%（安慰剂），使用同一制造商的相同豆荚和果汁来测试总减少量的效果。
研究人员假设 NR 与较低的满意度、戒断抑制和使用意愿相关，并且与部分 NR 相比，这种影响在总体上以及在高依赖性用户和低依赖性用户之间更为明显。 拟议的研究旨在回答 3 个主要的监管问题：1) NR 是一种有前途的监管选择，可以减少 ENDS 成瘾性和使用； 2) 部分和全部 NR 对补偿性吸食和接触尼古丁和呼吸道毒物的影响是什么，以及 3) NR 在不同使用阶段对 ENDS 用户的影响是什么。 结合起来，这些研究将为 NR 法规限制 ENDS 的成瘾性和使用的潜力提供直接和标准化的证据，并帮助预测 NR 对 ENDS 用户接触有害有毒物质的任何潜在副作用。
研究类型
介入性
注册 (实际的)
116
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Florida
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Miami、Florida、美国、33199
- Florida International University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 35年 (成人)
接受健康志愿者
是的
描述
纳入标准：
- 一般健康个体（通过体检确定）。
- 年龄21-35岁。
- 愿意提供知情同意。
- 愿意按照研究方案的要求参加实验室。
- 电子烟使用者（定义为在过去 30 天内每天或偶尔使用电子烟）
- 在每次会议前 12 小时内戒掉电子烟
排除标准：
- 定期报告吸烟情况（过去一年每月 > 5 支香烟）。
- 报告在过去一年中经常使用任何其他烟草/尼古丁产品（例如水烟、烟斗、雪茄）。
- 正在哺乳或怀孕测试呈阳性（通过筛查时的尿液分析）的女性。
- 自我报告有慢性病史或当前精神状况的个人。
- 有心血管疾病史或活动性心血管疾病、低血压或高血压、癫痫发作和经常使用处方药（维生素或避孕药除外）的个人。
- 报告当前吸食 THC（大麻）/电子烟的个人。
- 报告使用非商业（即街头）电子烟液体或产品的个人
- 报告当前 EVALI 或 COVID-19 相关症状（即咳嗽、呼吸急促、胸痛、恶心、呕吐、腹痛、腹泻、发烧、发冷或体重减轻）的个人
- 在过去 14 天内接触过或接触过 COVID-19 的个人。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Partial Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration
For the partial nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes.
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Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 5% nicotine concentration nicotine concentration
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实验性的：Partial Nicotine Reduction: Electronic cigarette pods with 3% or 2.4% nicotine concentration
For the partial nicotine reduction study, participants will complete a lab visit where they will use 3% or 2.4% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes.
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Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 3% or 2.4% nicotine concentration
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实验性的：Total Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration
For the total nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes.
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Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 5% nicotine concentration
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实验性的：Total Nicotine Reduction: Electronic cigarette pods with 0% nicotine concentration
For the total nicotine reduction study, participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes.
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Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 0% nicotine concentration nicotine concentration
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Plasma Nicotine Boost
大体时间：During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
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Change in plasma nicotine level.
The plasma nicotine boost was calculated by subtracting the preplasma nicotine value from the postplasma value.
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During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Puff Topography (Total Puffing Time)
大体时间：During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior in total puffing time
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Average Puff Duration)
大体时间：During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior in average puffing duration
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Puff Number)
大体时间：During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior; mean of the number of puffs taken during the ad-libitum smoking session
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Inhaled Volume)
大体时间：During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior; mean volume of puffs inhaled during the ad-libitum smoking session
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Toxicants (Carcinogenic and Probably or Possibly Carcinogenic) Exposure
大体时间：During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants.
The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN).
The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis.
The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis.
ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
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During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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TPM (Total Particular Matter) Exposure
大体时间：During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants.
The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN).
The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis.
The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis.
ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
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During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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Lung Function Tests (LFTs) Change
大体时间：During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use.
According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., change in FVC and FEV1) will be performed.
Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
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During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Lung Function Tests (LFTs) (% Predicted Change)
大体时间：During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use.
According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., % predicted value pred (FVC), FEV1 % pred FEV1/FVC, % pred) will be performed.
Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
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During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Minnesota Nicotine Withdrawal Scale (MNWS)
大体时间：During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Nicotine withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS) before and after each vaping session.
MNWS evaluates 11 withdrawal-related symptoms, including depressed mood, irritability, restlessness, hunger, and difficulty concentrating, using scale from "0" (not at all) to "100" (extremely).
For each session and condition, change scores were calculated by subtracting pre-session from post-session scores for each individual item
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During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Tiffany-Drobes Questionnaire of Smoking Urges (QSU)
大体时间：During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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The Tiffany-Drobes Questionnaire of Smoking Urges-Brief (QSU-Brief) is a 10-item self-report measure of cigarette craving and urge to smoke. It consists of two subscales representing distinct dimensions of craving: Factor 1 (Desire and Intention to Smoke): assesses desire, intention, and anticipation of pleasure associated with smoking. Factor 2 (Anticipation of Relief from Negative Affect and Withdrawal): assesses expectations that smoking will relieve withdrawal symptoms or negative affect. Each item is rated on a 7-point Likert scale ranging from 1 = strongly disagree to 7 = strongly agree. Subscale scores were calculated by averaging the items within each factor. Higher scores on either factor indicate greater smoking urge or craving, representing a worse outcome, whereas lower scores indicate lower craving or urge to smoke, representing a better outcome. Pre- to post-session change scores were calculated as pre-session score minus post-session score for each factor. |
During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Duke Sensory Questionnaire (DSQ)
大体时间：During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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This scale will assess participants sensory experience of the inhaled product.
The scale has nine items.
All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
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During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Modified Cigarette Evaluation Questionnaire (mCEQ)
大体时间：During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Modified Cigarette Evaluation Questionnaire (mCEQ) is used to assess subjective effects associated with ENDS use. The 11-item questionnaire evaluates satisfaction, psychological reward, enjoyment of respiratory tract sensations, craving reduction and aversion. Individual item scores were reported (not subscales). Each item was rated using 7-point Likert scale; 1 = not at all to 7 = extremely. For all items, higher scores indicate greater endorsement of the measured subjective experience, while lower scores indicate less endorsement of that experience. The interpretation depends on the construct being measured: For items assessing satisfaction, enjoyment, psychological reward, sensory experiences, and craving reduction, higher scores indicate greater product reinforcement or abuse liability. For items assessing aversion, higher scores indicate greater unpleasant effects or product aversiveness. |
During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Visual Analogue Scale (VAS)
大体时间：During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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This scale contains 10-item questions to assess users' pleasure and enjoyment using the validated Visual Analog Scale (VAS) post ENDS use sessions.
The scale includes items to assess user's desire, pleasure, satisfaction, future use, and other information rated on an analog scale (0 not at all to 100 extremely).
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During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Heart Rate
大体时间：During participants' 2 study visits. Heat rate will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in heart rate, measured in beats per minute (bpm).
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During participants' 2 study visits. Heat rate will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Blood Pressure (Systolic)
大体时间：During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in systolic blood pressure, measured in mm/hg.
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During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Blood Pressure (Diastolic)
大体时间：During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in diastolic blood pressure, measured in mm/hg.
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During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Wasim Maziak, PhD, MD、Florida International University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ferdous T, Roy S, Chowdhury S, Jebai R, Maya L, DeCaprio AP, Bursac Z, Maziak W. Partial Nicotine Reduction and E-Cigarette Users' Puffing Behaviors Among Adults Aged 21 to 35 Years: A Randomized Crossover Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422954. doi: 10.1001/jamanetworkopen.2024.22954.
- Roy S, Chowdhury S, Ferdous T, Shihadeh A, Salman R, El Hage R, Salam S, Bursac Z, Maziak W. Predicting nicotine emissions and plasma nicotine boost in E-cigarette users using machine learning. Sci Rep. 2026 Jun 13. doi: 10.1038/s41598-026-57341-4. Online ahead of print.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年4月1日
初级完成 (实际的)
2025年4月15日
研究完成 (实际的)
2025年4月15日
研究注册日期
首次提交
2021年12月15日
首先提交符合 QC 标准的
2022年1月19日
首次发布 (实际的)
2022年1月25日
研究记录更新
最后更新发布 (实际的)
2026年8月13日
上次提交的符合 QC 标准的更新
2026年8月10日
最后验证
2025年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.