- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03589599
Understanding the Effect of Flavor on Hookah Smoking Experience
30 juillet 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
144
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Florida
-
Miami, Florida, États-Unis, 33199
- Florida International University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 30 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Plasma nicotine
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Échelle de sevrage de la nicotine du Minnesota
Délai: Lors de la 1ère et de la 2ème visite des participants. Le questionnaire sera administré 2 fois lors de chaque séance de fumage : avant et après une période d'utilisation ad lib d'environ 45 minutes.
|
Cette échelle est utilisée pour évaluer dans quelle mesure l'utilisation du produit réduit les symptômes d'abstinence tabagique et se compose de 11 éléments notés de 0 à 100.
Ces éléments sont présentés sous forme d'échelle visuelle analogique avec l'élément (mesure) centré au-dessus d'une ligne horizontale ancrée à gauche avec pas du tout et à droite avec extrêmement.
|
Lors de la 1ère et de la 2ème visite des participants. Le questionnaire sera administré 2 fois lors de chaque séance de fumage : avant et après une période d'utilisation ad lib d'environ 45 minutes.
|
|
Puff topography
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heart rate
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 mars 2017
Achèvement primaire (Réel)
30 juin 2020
Achèvement de l'étude (Réel)
30 juin 2020
Dates d'inscription aux études
Première soumission
11 juin 2018
Première soumission répondant aux critères de contrôle qualité
5 juillet 2018
Première publication (Réel)
18 juillet 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 août 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 juillet 2020
Dernière vérification
1 juillet 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- R01DA042477 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .