“无烟草”口服尼古丁袋对吸烟者的急性药代动力学和药效学影响
2026年6月25日 更新者：Johns Hopkins University
本研究的目的是检查不同剂量和口味的“无烟草”口服尼古丁袋在健康成年吸烟者中的药代动力学和药效学。
该研究将采用受试者内双盲设计。
报名后，参与者将完成7种剂量条件：烟草味小袋（尼古丁剂量低或高），薄荷/薄荷味袋（尼古丁剂量低或高），水果味袋（尼古丁剂量低或高）；参与者还将完成一个条件，在该条件下，参与者将吸食参与者喜欢的香烟品牌。
在每个实验环节中，参与者将完成 2 次产品使用回合。
在第 1 轮中，参与者将在受控条件下使用单一产品（小袋或香烟）一段固定的时间。
在第 2 轮中，参与者将有 2 小时的时间随意使用参与者分配的产品。
研究概览
详细说明
本研究的目的是检查不同剂量和口味的“无烟草”口服尼古丁袋在健康成年吸烟者中的药代动力学和药效学。
该研究将采用受试者内双盲设计。
报名后，参与者将完成7种剂量条件：烟草味小袋（尼古丁剂量低或高），薄荷/薄荷味袋（尼古丁剂量低或高），水果味袋（尼古丁剂量低或高）；参与者还将完成一个条件，在该条件下，参与者将吸食参与者喜欢的香烟品牌。
在每个实验环节中，参与者将完成 2 次产品使用回合。
在第 1 轮中，参与者将在受控条件下使用单一产品（小袋或香烟）一段固定的时间。
在第 2 轮中，参与者将有 2 小时的时间随意使用参与者分配的产品。
将在整个会议期间获取血液样本，以表征尼古丁的药代动力学，还将评估各种药效学结果（主观药物效应、烟草戒断症状、生命体征）。
这些程序将由每个参与者完成 7 次（在单独访问时）（会议将至少间隔 48 小时）。
研究类型
介入性
注册 (实际的)
71
阶段
- 阶段1
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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Maryland
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Baltimore、Maryland、美国、21224
- Johns Hopkins Behavioral Pharmacology Research Unit
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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 及以上 (成人、年长者)
接受健康志愿者
是的
描述
纳入标准：
- ≥21岁
- 基于筛查程序（例如，体检、血液检测）的良好总体健康状况
- 生命体征在正常范围内（静息心率小于100bpm，收缩压小于150mmHg，舒张压小于90mmHg）
- 筛查时和每次会议前的非法药物使用尿检（不包括四氢大麻酚）呈阴性，呼气酒精检测呈阴性
- 自我报告目前每天吸烟
- 自我报告至少一年的经常吸烟史
- 筛选时呼出气 CO 大于或等于 10ppm 且尿液可替宁大于 100 ng/ml
- 至少符合轻度烟草使用障碍的标准
- 在过去 30 天内没有自我报告经常使用其他烟草产品（例如无烟产品、电子烟）
- 没有自我报告之前使用过新型口服尼古丁袋
- 每次学习会议到达时呼出的一氧化碳低于 10 ppm。
排除标准：
- 上个月使用精神药物（大麻、尼古丁、酒精或咖啡因除外）
- 当前使用研究人员或医务人员认为会影响安全的非处方药 (OTC)、补充剂/维生素或处方药
- 每周使用大麻 >4 次
- 研究人员或医务人员认为会影响安全性的历史或当前重大医疗状况
- 研究人员或医务人员认为会影响安全或研究结果的当前精神状况或物质使用障碍（烟草使用障碍除外）
- 怀孕、计划怀孕或正在哺乳的妇女
- 目前正在寻求戒烟治疗或正在使用尼古丁/戒烟产品。
- 在过去 30 天内参加过另一项临床试验
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：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：原味/烟草味小袋（低尼古丁剂量）
参与者将在受控（实验者指导）和随意使用条件下使用烟草味袋（4mg 尼古丁剂量）
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尼古丁袋将自行管理
其他名称：
|
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实验性的：原味/烟草味小袋（高尼古丁剂量）
参与者将在受控（实验者指导）和随意使用条件下使用烟草味小袋（8 毫克尼古丁剂量）
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尼古丁袋将自行管理
其他名称：
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实验性的：薄荷/薄荷味袋装（低尼古丁剂量）
参与者将在受控（实验者指导）和随意使用条件下使用薄荷/薄荷味袋（4mg 尼古丁剂量）
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尼古丁袋将自行管理
其他名称：
|
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实验性的：薄荷/薄荷味袋装（高尼古丁剂量）
参与者将在受控（实验者指导）和随意使用条件下使用薄荷/薄荷味袋（8 毫克尼古丁剂量）
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尼古丁袋将自行管理
其他名称：
|
|
实验性的：水果味袋装（低尼古丁剂量）
参与者将在受控（实验者指导）和随意使用条件下使用水果味小袋（4mg 尼古丁剂量）
|
尼古丁袋将自行管理
其他名称：
|
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实验性的：水果味袋装（高尼古丁剂量）
参与者将在受控（实验者指导）和随意使用条件下使用水果味小袋（8 毫克尼古丁剂量）
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尼古丁袋将自行管理
其他名称：
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有源比较器：自有品牌香烟
参与者将在受控（实验者指导）和随意使用条件下吸参与者自己品牌的香烟
|
香烟会被抽
其他名称：
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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 |
|---|---|---|
|
Pharmacokinetics of Nicotine as Assessed by the Cmax (20-min Directed Bout)
大体时间：0 to 1 hour
|
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine.
Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product.
Bout 1 (20min directed use) Cmax was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
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0 to 1 hour
|
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Pharmacokinetics of Nicotine as Assessed by the AUC (20 Min Directed Bout)
大体时间：0 to 1 hour
|
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine.
Area under the curve (AUC), represents the total nicotine exposure during an entire nicotine use period and provides important insight into the abuse liability of a tobacco product.
Data is reported as the mean (SD) change from baseline.
Bout 1 (20min directed use) AUC was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
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0 to 1 hour
|
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Peak Change From Baseline Subjective Ratings of "Like Drug Effect" as Assessed by the Drug Effect Questionnaire
大体时间：Up to 6.5 hours
|
The DEQ will be used to obtain subjective ratings of "like drug effect".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater liking.
Data is reported as mean (SD) change from baseline.
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
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Up to 6.5 hours
|
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Subjective Ratings of "Pleasant Drug Effect" as Assessed by the Drug Effect Questionnaire
大体时间：Up to 6.5 hours
|
The DEQ will be used to obtain subjective ratings of "pleasant drug effect".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "pleasant drug effect".
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
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Up to 6.5 hours
|
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Subjective Ratings of "Take Again" as Assessed by the Drug Effect Questionnaire
大体时间：Up to 6.5 hours
|
The DEQ will be used to obtain subjective ratings of "take again".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "take again" rating.
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
|
Up to 6.5 hours
|
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Subjective Ratings of "Urge to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
大体时间：Up to 6.5 hours
|
The HHWS will be used to obtain subjective ratings of "urge to smoke".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "urge to smoke".
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
|
Up to 6.5 hours
|
|
Subjective Ratings of "Craving to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
大体时间：Up to 6.5 hours
|
The HHWS will be used to obtain subjective ratings of "craving to smoke".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "craving to smoke".
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
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Up to 6.5 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacokinetics of Nicotine as Assessed by the Tmax
大体时间：Up to1 hour
|
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine.
Time to maximum concentration (Tmax), is the time (in minutes) to reach Cmax.
This is another measure relevant for abuse liability.
Tmax for bout 1 was calculated based on post-baseline blood timepoints which include 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
|
Up to1 hour
|
|
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 1 (Change From Baseline)
大体时间：Up to 6.5 hours
|
The QSU-brief factor 1 (intention to smoke) measures tobacco withdrawal symptoms using 5 items; scores are summed to produce a single score ranging from 0 to 30.
Higher scores indicates greater withdrawal symptoms.
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
|
Up to 6.5 hours
|
|
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 2 (Change From Baseline)
大体时间：6.5 hours
|
The QSU-brief factor 2 (anticipation of relief) measures tobacco withdrawal symptoms using 5 items; scores are summed to produce a single score ranging from 0 to 24.
Higher scores indicates greater/worse withdrawal symptoms.
|
6.5 hours
|
|
Topography as Assessed by the Total Time of Use
大体时间：2 hours
|
During the 2 hour ad libitum bout, topography will be collected.
The total time of use (out of 2 hours) will be assessed.
|
2 hours
|
|
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
大体时间：6.5 hours
|
The DENS will assess nicotine-specific effects.
Scores on all items range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher scores indicates stronger (better) nicotine related effects.
|
6.5 hours
|
|
Perceived Strength of Effects as Assessed by the Drug Effect Questionnaire
大体时间：Up to 6.5 hours
|
The DEQ will assess subjective ratings for "feel drug effect".
Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "feel drug effect".
Higher scores indicates stronger (better) effects.
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
|
Up to 6.5 hours
|
|
Negative and Aversive Effects as Assessed by the Drug Effect Questionnaire
大体时间：Up to 6.5 hours
|
The DEQ will assess subjective ratings for "dislike drug effect".
Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating a stronger (worse) perception of aversive or unpleasant drug effects.
A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
|
Up to 6.5 hours
|
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：Tory Spindle, PhD、Johns Hopkins University
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7月27日
初级完成 (实际的)
2025年8月29日
研究完成 (实际的)
2025年8月29日
研究注册日期
首次提交
2022年4月12日
首先提交符合 QC 标准的
2022年4月12日
首次发布 (实际的)
2022年4月20日
研究记录更新
最后更新发布 (实际的)
2026年7月23日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6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.