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Abuse Liability of Reduced Nicotine Content Cigarettes Within a Complex Tobacco Marketplace

26 de agosto de 2021 atualizado por: Warren K. Bickel, Virginia Polytechnic Institute and State University
Tobacco regulatory policies can have unanticipated consequences; therefore, methods that would permit prospective estimates of the effects of potential tobacco regulations are necessary for the development of tobacco regulatory science. The goal of this project is to experimentally assess how smokers purchase and consume reduced-nicotine cigarettes. In experiment 1, we will investigate how purchasing/consuming reduced-nicotine cigarettes is related to nicotine content and absorption. In experiment 2, we will investigate how purchasing/consuming changes when other nicotine products are available in an experimental marketplace setting. The proposed projects can directly inform tobacco regulation by providing estimates of the real-world effects of novel policies.

Visão geral do estudo

Descrição detalhada

The specific objective in Experiment 1 is to examine the effect of nicotine content (0.4 mg/g, 1.4 mg/g, 2.5 mg/g, 5.6 mg/g, and 17.4 mg/g of tobacco) and blood nicotine absorption on laboratory behavioral economic measures of demand intensity and elasticity. Under double-blind conditions, we will examine the relationship between plasma nicotine and cigarette demand as a function of the dose of the nicotine in the cigarettes. Regular cigarette smokers will consume, on separate sessions, controlled puffs of a cigarette containing a blinded dose of nicotine then complete a cigarette purchase task, our measure of value, while plasma nicotine is measured. We hypothesize that cigarette demand will be associated with dose and level of circulating nicotine, but in a nonlinear fashion such that consumption of very low dose cigarettes will not be predicted by nicotine dose or intake alone.

To inform how various products may interact, we have developed and tested a novel method called the Experimental Tobacco Marketplace. The Experimental Tobacco Marketplace is a systematic extension of similar marketplace methods used with other consumer products (e.g., food marketplaces used in obesity and other nutrition-related research; Epstein, Dearing, Roba, & Finkelstein, 2010). In experimental marketplaces, multiple products are available and the experimenter controls the prices for each. These marketplaces can be either physical or virtual stores (similar to online retailers) and permit the examination of demand elasticity and intensity and degree of substitution or complementarity in consumer behavior under conditions that approximate naturalistic settings.

Experiment 2 will extend findings from the first experiment examining the effects of different concentrations of nicotine in cigarettes (0.4mg/g, 1.4mg/g, 2.5mg/g, 5.6mg/g, 17.4mg/g) and blood nictotine absorption on laboratory behavioral economic demand measures. Employing this innovative Experimental Tobacco Marketplace, we propose to examine reduced-nicotine cigarettes under the following conditions: 1) control conditions where lower dose nicotine cigarettes are the only available product in the Experimental Tobacco Marketplace and where the tobacco marketplace is similar to the current real-world marketplace (i.e., no lower dose nicotine cigarettes, but a variety of other tobacco products); 2) lower dose nicotine cigarettes are available with a number of other nicotine products excluding conventional cigarettes; and 3) lower dose nicotine cigarettes are available with a number of other nicotine products including conventional cigarettes.

Tipo de estudo

Intervencional

Inscrição (Real)

305

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.

Locais de estudo

    • Virginia
      • Roanoke, Virginia, Estados Unidos, 24016
        • Fralin Biomedical Research Institute at VTC

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

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • smoke at least 5 cigarettes per day
  • have a breath carbon monoxide (CO) level of at least 10 ppm at intake
  • no immediate plans to quit smoking.

Exclusion Criteria:

  • pregnant, lactating, plans to become pregnant
  • weigh more than 110lbs (experiment 1 only)
  • have plans to move out of the area during the course of the experiment

To see if you are eligible, use the following confidential link: http://vtcri.info/arrcclinicaltrials

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: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Single arm
All participants will complete the same experimental events across 6 laboratory sessions.
Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
Experimental: 0.4 mg/g Concentration
Participants in this arm will experience the 0.4 mg/g Concentration
Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
Experimental: 1.3 mg/g Concentration
Participants in this arm will experience the 1.3 mg/g Concentration
Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
Experimental: 2.4 mg/g Concentration
Participants in this arm will experience the 2.4 mg/g Concentration
Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
Experimental: 5.2 mg/g Concentration
Participants in this arm will experience the 5.2 mg/g Concentration
Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
Experimental: 15.8 mg/g Concentration
Participants in this arm will experience the 15.8 mg/g Concentration
Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task
Prazo: 10 minutes after cigarette administration
The Cigarette Purchase Task is a behavioral economic measure of abuse liability that consists of a series of hypothetical questions asking participants to indicate how many cigarettes they would purchase for their own consumption across a range of cigarette prices. Participants smoked one cigarette and then were asked to report how many cigarettes they would smoke within a 24 hour period at the following prices: $0.00 (free), $0.01, $0.05, $0.10, $0.25, $0.50, $1, $2, $5, $10, $25, $50, $100, $200. Nonlinear regression was then used to estimate the number of cigarettes participants would take when they were free using the equation by Koffarnus et al. (2015; doi:10.1037/pha0000045). The outcome is the logarithmically transformed number of cigarettes.
10 minutes after cigarette administration
Change in Blood Nicotine Content Over the Course of the Session
Prazo: Each session (6 sessions total) with at least 2 days between each session.
For participants in the single arm only, blood will be collected throughout each session and analyzed for nicotine content. The change in blood nicotine content over the course of the session will be compared among the six sessions where different cigarettes were administered. Blood nicotine (expressed in ng/mL) at minute 0 was subtracted from blood nicotine at minutes 10, 15, 20, 30, 45, and 60 to yield a change in blood nicotine (negative values were truncated to 0) at each of the time points. Using these change in blood nicotine values, we calculated Area Under the Curve (AUC) via the trapezoidal rule, which resulted in a singular number (total change in blood nicotine over the course of each experimental session) in our primary outcome measure.
Each session (6 sessions total) with at least 2 days between each session.
Experimental Marketplace Purchases
Prazo: Sessions 2-5 with each session conducted one week apart (for 4 weeks total)
In all arms except the single arm, measures of quantities of experimental cigarettes and other nicotine products will be obtained.
Sessions 2-5 with each session conducted one week apart (for 4 weeks total)

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Warren K Bickel, PhD, Virginia Polytechnic Institute and State University

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 (Real)

1 de janeiro de 2017

Conclusão Primária (Real)

1 de novembro de 2019

Conclusão do estudo (Real)

1 de novembro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

27 de outubro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de outubro de 2016

Primeira postagem (Estimativa)

1 de novembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de setembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de agosto de 2021

Última verificação

1 de agosto de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • R01DA042535 (Concessão/Contrato do NIH dos EUA)

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 .

Ensaios clínicos em SPECTRUM cigarettes

3
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