Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability

Обзор

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.

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.

Вмешательства

• Поведенческое Biospecimen Collection
  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.
• Поведенческое Questionnaire Administration
  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.
• Поведенческое Cigarette Purchase Task
  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.
• Поведенческое Cross-Price Elasticity Task
  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.
• Поведенческое Daily Diary Surveys
  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.
• Поведенческое Progressive Ratio Task
  A concurrent choice task administered at the final laboratory visit.

Первичные конечные точки

• Plasma nicotine (Cmax) [Срок оценки: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks]

Вторичные конечные точки (12)

• Appeal ratings (Labeled Hedonic Scale) [Срок оценки: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks]
• Puff topography [Срок оценки: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks]
• Sensory effects (general Labeled Magnitude Scale) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks]
• Breakpoint [Срок оценки: Post Phase 2 smoking sessions, assessed up to 3 weeks]
• Demand intensity (Q0) [Срок оценки: Post Phase 2 smoking sessions, assessed up to 3 weeks]
• Maximum financial expenditure on cigarettes (Omax) [Срок оценки: Post Phase 2 smoking sessions, assessed up to 3 weeks]
• Price at which expenditure is maximized (Pmax) [Срок оценки: Post Phase 2 smoking sessions, assessed up to 3 weeks]
• Demand elasticity (alpha) [Срок оценки: Post Phase 2 smoking sessions, assessed up to 3 weeks]
• Cross-over price [Срок оценки: Post Phase 2 smoking sessions, assessed up to 3 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT07564648 · OSU-25014 · K01DA061444 · NCI-2026-01493

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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