Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
21 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
48
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: The Ohio State University Comprehensive Cancer Center
- Номер телефона: 800-293-5066
- Электронная почта: OSUCCCClinicaltrials@osumc.edu
Места учебы
-
-
Ohio
-
Columbus, Ohio, Соединенные Штаты, 43210
- Ohio State University Comprehensive Cancer Center
-
Контакт:
- Yoo Jin Cho, PhD, MPH
- Номер телефона: 614-366-7048
- Электронная почта: Yoojin.cho@osumc.edu
-
Главный следователь:
- Yoo Jin Cho, PhD, MPH
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Plasma nicotine (Cmax)
Временное ограничение: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
|
Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
|
During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Appeal ratings (Labeled Hedonic Scale)
Временное ограничение: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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.
|
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
|
Puff topography
Временное ограничение: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
|
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.
|
During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
|
|
Sensory effects (general Labeled Magnitude Scale)
Временное ограничение: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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.
|
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
|
Nicotine craving and withdrawal (Questionnaire of smoking urges)
Временное ограничение: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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.
|
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
|
Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
Временное ограничение: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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.
|
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
|
Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
Временное ограничение: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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.
|
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
|
Breakpoint
Временное ограничение: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Breakpoint will be defined as the first price at which cigarette consumption is zero during the Cigarette Purchase Task (CPT).
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Demand intensity (Q0)
Временное ограничение: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Demand intensity will be defined as cigarette consumption at the lowest cigarette price of $0 during the Cigarette Purchase Task (CPT).
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Maximum financial expenditure on cigarettes (Omax)
Временное ограничение: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the maximum financial expenditure.
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Price at which expenditure is maximized (Pmax)
Временное ограничение: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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.
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Demand elasticity (alpha)
Временное ограничение: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Sensitivity of cigarette consumption to increase in price assessed using the Cigarette Purchase Task (CPT).
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Cross-over price
Временное ограничение: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
The price at which two options valued approximately equally will be calculated from the Cross Price Elasticity Task (CPET).
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Progressive ratio task
Временное ограничение: 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
|
|
Preferred product selection
Временное ограничение: Post Phase 2 smoking sessions, assessed up to 3 weeks
|
Count of participants selecting each of the 3 study products after completion of the 3 Phase 2 smoking sessions.
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Product substitution
Временное ограничение: 1 week Phase 3 substitution period
|
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.
|
1 week Phase 3 substitution period
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Yoo Jin Cho, PhD, MPH, Ohio State University Comprehensive Cancer Center
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
27 июля 2026 г.
Первичное завершение (Оцененный)
30 сентября 2029 г.
Завершение исследования (Оцененный)
30 сентября 2029 г.
Даты регистрации исследования
Первый отправленный
27 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
27 апреля 2026 г.
Первый опубликованный (Действительный)
4 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
22 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- OSU-25014
- K01DA061444 (Грант/контракт NIH США)
- NCI-2026-01493 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .