- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03589599
Understanding the Effect of Flavor on Hookah Smoking Experience
30 de julio de 2020 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
144
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Florida
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Miami, Florida, Estados Unidos, 33199
- Florida International University
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 30 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
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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.
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Effects of non-flavored tobacco
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Plasma nicotine
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Escala de abstinencia de nicotina de Minnesota
Periodo de tiempo: Durante la 1ª y 2ª visita de los participantes. El cuestionario se administrará 2 veces en cada sesión de fumar: antes y después de un período de uso ad libitum de aproximadamente 45 minutos.
|
Esta escala se utiliza para evaluar en qué medida el uso del producto reduce los síntomas de abstinencia del tabaco y consta de 11 ítems puntuados de 0 a 100.
Estos ítems se presentan como escala analógica visual con el ítem (medida) centrado sobre una línea horizontal anclada a la izquierda con nada ya la derecha con extremadamente.
|
Durante la 1ª y 2ª visita de los participantes. El cuestionario se administrará 2 veces en cada sesión de fumar: antes y después de un período de uso ad libitum de aproximadamente 45 minutos.
|
|
Puff topography
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
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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.
|
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Duke Sensory Questionnaire
Periodo de tiempo: 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.
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The Cigarette/WP Evaluation Scale (WES)
Periodo de tiempo: 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.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Heart rate
Periodo de tiempo: During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr
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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
|
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Blood pressure
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de marzo de 2017
Finalización primaria (Actual)
30 de junio de 2020
Finalización del estudio (Actual)
30 de junio de 2020
Fechas de registro del estudio
Enviado por primera vez
11 de junio de 2018
Primero enviado que cumplió con los criterios de control de calidad
5 de julio de 2018
Publicado por primera vez (Actual)
18 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
30 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- R01DA042477 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .