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Understanding the Effect of Flavor on Hookah Smoking Experience

30 de julho de 2020 atualizado por: Wasim Maziak, phd, Florida International University

Understanding Tobacco Flavor Effects on Waterpipe Smokers' Experiences and Exposures

This project addresses the need for evidence about the effect of flavoring manipulation on waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure. Specifically, in this clinical study investigators will compare the effect on flavored and non-flavored waterpipe tobacco on smoking behavior, subjective experiences and toxicant exposure among waterpipe users. Findings from this study will help informing flavor-based product regulation by the FDA.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Waterpipe (WP) tobacco smoking (a.k.a. hookah, shisha, narghile) is increasing rapidly in the United States (US), particularly among young people. Evidence suggests that WP smoking can lead to dependence, other tobacco use, and many of the known smoking-related diseases including cancer, cardiovascular disease and adverse pregnancy outcomes. These alarming trends led the Food and Drug Administration (FDA) in 2014 to propose including the WP under its regulatory authority, allowing the FDA to apply evidence-based regulatory approaches to control WP spread in the US. Given the salience of flavored tobacco in shaping the "WP experience", regulating WP tobacco flavor represents a promising approach for the FDA to curb WP use among US youth. This project aims to assist the FDA in these efforts by providing answers to specific questions pertinent to the potential of WP regulation through flavor. These include: - How would flavor manipulation affect the smoking experience and satisfaction of WP users at different stages of their smoking trajectory - How would smoking non-preferred flavor or unflavored WP tobacco reflects on smokers' exposure to nicotine, and dependence; and - How would flavor manipulation influence puffing behavior and exposure to toxicants such as carbon monoxide (CO) among WP smokers. Answers to these questions will help the FDA predict the impact of flavor regulation on WP experimentation and continued use. In this study, investigators will use clinical laboratory methods to answer these questions. Two groups of WP smokers will be recruited based on their use frequency: low (Beginners) vs. high frequency (Experienced) smokers (72/group; total 144; age 18-30). Each participant will undergo 2 WP smoking sessions that differ by flavor (preferred flavor; unflavored), while measurement of WP satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted. The response of WP smokers at different stages of their WP smoking trajectory (Beginners vs. Experienced) to flavor manipulation, will allow to predict the effect of limiting flavors on a wide range of WP smokers. This project promises to provide the first evidence to guide the FDA in terms of the potential of regulating WP flavored tobacco on WP uptake and use in the US.

Tipo de estudo

Intervencional

Inscrição (Real)

144

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

    • Florida
      • Miami, Florida, Estados Unidos, 33199
        • Florida International University

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 30 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Generally healthy individuals (determined by physical examination).
  • Age of 18-30 years.
  • Is willing to provide informed consent.
  • Is willing to attend the lab as required by the study protocol.
  • WP smokers who smoke flavored WP tobacco.
  • Have abstained from WP for 12 hours prior to each session

Exclusion Criteria:

  • Report smoking cigarettes regularly (> 5 cigarettes/month in the past year).
  • Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
  • Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
  • Individuals with self-reported history of chronic disease or psychiatric conditions.
  • Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).

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: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Flavored tobacco
All participants will be completing a lab visit where they smoke flavored waterpipe tobacco ad lib for up to 45 min.
Effects of flavored tobacco
Experimental: Non-flavored tobacco
All participants will be completing a lab visit where they smoke non-flavored waterpipe tobacco ad lib for up to 45 min.
Effects of non-flavored tobacco

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Plasma nicotine
Prazo: During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period
Change in plasma nicotine level
During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Escala de Abstinência de Nicotina de Minnesota
Prazo: Durante a 1ª e 2ª visita dos participantes. O questionário será administrado 2 vezes em cada sessão de fumar: antes e depois de um período de uso ad lib de aproximadamente 45 minutos.
Essa escala é usada para avaliar até que ponto o uso do produto reduz os sintomas de abstinência do tabaco e consiste em 11 itens pontuados de 0 a 100. Esses itens são apresentados como Escala Visual Analógica com item (medida) centralizado acima de uma linha horizontal ancorada à esquerda com nada e à direita com extremamente.
Durante a 1ª e 2ª visita dos participantes. O questionário será administrado 2 vezes em cada sessão de fumar: antes e depois de um período de uso ad lib de aproximadamente 45 minutos.
Puff topography
Prazo: During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period)
measurement of puffing behavior
During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period)
Tiffany-Drobes Questionnaire of Smoking Urges
Prazo: During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree).
During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
Carbon monoxide levels
Prazo: During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period
Change in carbon monoxide levels (in parts per mission)
During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period
Harm perception
Prazo: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
This scale assess waterpipe harm perception and measure perceptions of waterpipe relative risk compared to cigarettes. The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful).
During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
Duke Sensory Questionnaire
Prazo: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
This scale assess participants sensory experience of the inhaled product. The scale has nine items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
The Cigarette/WP Evaluation Scale (WES)
Prazo: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
This scale assesses participants' perception of the smoked waterpipe, The scale has 11 items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Heart rate
Prazo: During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr
Change in heart rate, measured in beats per minute
During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr
Blood pressure
Prazo: During participants' 1st and 2nd visit. Blood pressure will be measured from baseline continuously throughout each approximately 45-min session
Change in blood pressure, measured in mm/hg
During participants' 1st and 2nd visit. Blood pressure will be measured from baseline continuously throughout each approximately 45-min session

Colaboradores e Investigadores

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

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)

21 de março de 2017

Conclusão Primária (Real)

30 de junho de 2020

Conclusão do estudo (Real)

30 de junho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

11 de junho de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de julho de 2018

Primeira postagem (Real)

18 de julho de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de agosto de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de julho de 2020

Última verificação

1 de julho de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • R01DA042477 (Concessão/Contrato do NIH dos EUA)

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

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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