Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
2026年7月21日 更新者：Yoojin Cho、Ohio State University Comprehensive Cancer Center
This randomized, double-blind, crossover human laboratory study compares the abuse liability of cigarettes containing menthol and non-menthol cigarette variants, using the participant's usual brand menthol cigarette as a within-subject reference.
Participants complete standardized laboratory smoking sessions, behavioral economic tasks, and a naturalistic observational period.
The study examines differences in nicotine delivery, smoking behavior, and subjective effects across cigarette types in laboratory and real-world contexts.
研究概览
地位
尚未招聘
详细说明
Participants complete a three-phase protocol over approximately three weeks, comprising five in-person laboratory visits and two one-week daily-diary periods.
In Phase 1, participants attend a 3-hour baseline laboratory visit after a 12-hour abstinence from nicotine, tobacco, and smoked cannabis. They smoke one usual brand menthol cigarette (UBMC) in a standardized session (10 puffs over 5 minutes) while puff topography is recorded. Serial 3 mL blood samples are collected at -5, +5, +15, +30, and +60 minutes relative to smoking initiation. Subjective effects (e.g., product appeal, sensory perception, craving) are assessed before and after smoking, followed by the Cigarette Purchase Task (CPT). Participants then complete brief surveys three times daily for one week to capture product use and subjective effects in the natural environment.
In Phase 2, participants return for three additional laboratory visits, each separated by at least 48 hours, and smoke one of three blinded study products in a randomized order; study coordinators remain blinded. Each visit follows the Phase 1 procedures (standardized smoking session, topography, serial blood sampling, and subjective ratings). After smoking, participants complete the CPT and the Cross-Price Elasticity Task (CPET), in which the price of UBMC increases while the study product remains fixed, characterizing substitutability.
In Phase 3, participants identify their preferred study product and receive a one-week supply, with instructions to use it exclusively in place of their UBMC. They continue the three-times-daily survey schedule throughout the week. The phase concludes with a final 2-hour laboratory visit including a remaining-cigarette count and the Progressive Ratio Task (PRT), providing a measure of the relative reinforcing value of the preferred study product vs. UBMC.
研究类型
介入性
注册 (估计的)
48
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。
学习联系方式
- 姓名：The Ohio State University Comprehensive Cancer Center
- 电话号码：800-293-5066
- 邮箱：OSUCCCClinicaltrials@osumc.edu
学习地点
-
-
Ohio
-
Columbus、Ohio、美国、43210
- Ohio State University Comprehensive Cancer Center
-
接触：
- Yoo Jin Cho, PhD, MPH
- 电话号码：614-366-7048
- 邮箱：Yoojin.cho@osumc.edu
-
首席研究员：
- Yoo Jin Cho, PhD, MPH
-
-
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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Aged 21 years or older
- Currently smoke cigarettes daily (≥ 5 cigarettes/day) for at least the past 6 months, and their usual brand is menthol cigarettes
- Willing to provide informed consent
- Willing to abstain from all nicotine, tobacco, and smoked cannabis products for approximately 12 hours prior to each study visit
- Own and regularly use a functional smartphone compatible with study procedures (e.g., completing daily assessments)
- Willing to complete two weeks of daily assessments involving use of their usual brand menthol cigarettes and the study product
- Able to read, speak, and understand English
Exclusion Criteria:
- Current diagnosis of any significant lung diseases (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis)
- History of a cardiac event or episode of cardiac distress (e.g., heart attack, hospitalization for chest pain) within the past 3 months
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Self-reported use of any non-cigarette nicotine or tobacco product (e.g., e-cigarettes, cigars, oral nicotine products) or cannabis on more than 10 days in the past 30 days
- Self-reported current participation in a smoking cessation program or intention to quit smoking in the next 3 months
- Self-reported difficulty with blood draws
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Study Cigarette A
Participants smoke one Study Cigarette A during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
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|
实验性的：Study Cigarette B
Participants smoke one Study Cigarette B during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
|
|
实验性的：Study Cigarette C
Participants smoke one Study Cigarette C during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
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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 (Cmax)
大体时间：During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
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During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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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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Appeal ratings (Labeled Hedonic Scale)
大体时间：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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The Labeled Hedonic Scale (LHS) is a self-reported measure of appeal.
Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Puff topography
大体时间：During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Puffing topography will be summarized with total puff count, average puff duration, average inter-puff interval, average puff volume, total puff volume, average flow rate, and peak flow rate.
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During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Sensory effects (general Labeled Magnitude Scale)
大体时间：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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The general Labeled Magnitude Scale (gLMS) is a 5-item self-report measure of sensory effects.
Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Nicotine craving and withdrawal (Questionnaire of smoking urges)
大体时间：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Craving relief will be assessed using Questionnaire of Smoking Urges (QSU).
The QSU is made up of 10 statements about the respondent's feelings and thoughts about desire to smoke cigarettes as they are completing the questionnaire.
The scoring comprises of two factors, each the sum of 5 items.
The scores for each factor range from 5-35, and the total score (the sum of all 10 items) ranges from 10-70.
For each factor and for the total score, higher scores indicate more severe urges.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
大体时间：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Withdrawal will be assessed using Minnesota Nicotine Withdrawal Scale (MNWS).
Items are rated on a 5-point scale from 0 (none) to 4 (severe).
MNWS is the sum of 8 items with scores ranging from 0 to 32 with higher scores indicating more severe overall withdrawal.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
大体时间：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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MNWS-Craving will be calculated which uses a single item from the MNWS that is scored from 0-4 with higher scores indicating greater craving.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Breakpoint
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Breakpoint will be defined as the first price at which cigarette consumption is zero during the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand intensity (Q0)
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand intensity will be defined as cigarette consumption at the lowest cigarette price of $0 during the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Maximum financial expenditure on cigarettes (Omax)
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the maximum financial expenditure.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Price at which expenditure is maximized (Pmax)
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the price at which expenditure is maximized.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand elasticity (alpha)
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Sensitivity of cigarette consumption to increase in price assessed using the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Cross-over price
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
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The price at which two options valued approximately equally will be calculated from the Cross Price Elasticity Task (CPET).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Progressive ratio task
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
|
The proportion of puffs allocated to the study products versus usual brand menthol cigarettes (UBMC) will be measured with the Progressive Ratio Task (PRT).
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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Preferred product selection
大体时间：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Count of participants selecting each of the 3 study products after completion of the 3 Phase 2 smoking sessions.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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Product substitution
大体时间：1 week Phase 3 substitution period
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Substitution assessed via use behavior during Phase 3 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time.
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1 week Phase 3 substitution period
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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：Yoo Jin Cho, PhD, MPH、Ohio State University Comprehensive Cancer Center
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。
有用的网址
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 (估计的)
2026年7月27日
初级完成 (估计的)
2029年9月30日
研究完成 (估计的)
2029年9月30日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年4月27日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- OSU-25014
- K01DA061444 (美国 NIH 拨款/合同)
- NCI-2026-01493 (注册表标识符：CTRP (Clinical Trial Reporting Program))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data will be archived through the National Addiction & HIV Data Archive Program (NAHDAP) at the Inter-university Consortium for Political and Social Research (ICPSR).
Access requires a Restricted Data Use Agreement.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.