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

21 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

48

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Ohio State University Comprehensive Cancer Center
        • Contato:
        • Investigador principal:
          • Yoo Jin Cho, PhD, MPH

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: Progressive Ratio Task
A concurrent choice task administered at the final laboratory visit.
Experimental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: Progressive Ratio Task
A concurrent choice task administered at the final laboratory visit.
Experimental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: Progressive Ratio Task
A concurrent choice task administered at the final laboratory visit.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Plasma nicotine (Cmax)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Appeal ratings (Labeled Hedonic Scale)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ohio State University Comprehensive Cancer Center

Colaboradores

National Institute on Drug Abuse (NIDA)

Investigadores

  • Investigador principal: Yoo Jin Cho, PhD, MPH, Ohio State University Comprehensive Cancer Center

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

27 de julho de 2026

Conclusão Primária (Estimado)

30 de setembro de 2029

Conclusão do estudo (Estimado)

30 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • OSU-25014
  • K01DA061444 (Concessão/Contrato do NIH dos EUA)
  • NCI-2026-01493 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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