Évaluation de l'effet de la réduction de la nicotine sur la dépendance et les expositions des utilisateurs d'ENDS
Aperçu de l'étude
Statut
Les conditions
Description détaillée
L'utilisation de systèmes électroniques de distribution de nicotine (ENDS ou e-cigarettes) a atteint des niveaux épidémiques chez les jeunes aux États-Unis (US). Les ENDS émettent des substances toxiques, dont la nicotine qui affecte de manière irréversible le cerveau en développement et entraîne une dépendance et un risque accru d'initiation à la cigarette. Les preuves indiquent que les jeunes qui utilisent ENDS sont susceptibles d'accélérer leur consommation et de devenir dépendants de la nicotine. Certains des ENDS les plus populaires parmi les jeunes (par ex. JUUL avec 5% de nicotine liquide) délivrent dans une cartouche une dose de nicotine égale à un paquet entier de cigarettes, et de nombreux utilisateurs ignorent cette exposition importante et le risque d'addiction qui y est associé. D'autre part, la réduction de la nicotine (NR) a été considérée par la Food and Drug Administration (FDA) des États-Unis comme une stratégie importante pour limiter la dépendance et l'utilisation des produits du tabac.
Maintenant que la FDA réglemente les ENDS en vertu de la «règle déterminative», une telle stratégie peut être envisagée pour ces produits du tabac émergents. Cependant, les chercheurs manquent encore de preuves sur les effets attendus d'une gamme de niveaux de NR sur les utilisateurs d'ENDS à différentes étapes de la trajectoire d'utilisation. À l'aide de méthodes de laboratoire cliniques et analytiques, les chercheurs prévoient de comparer, parmi les utilisateurs d'ENDS à 5 % de nicotine, l'effet d'une NR partielle (3 %) ou totale (sans nicotine, 0 %) sur la dépendance, la satisfaction, les effets cliniques (par ex. TA, oxymétrie, fonctions pulmonaires, symptômes), comportement de bouffées et exposition à des substances toxiques. Les chercheurs recruteront des utilisateurs actuels d'ENDS (n = 120 ; 21-35 ans) pour une étude de laboratoire croisée 2X2 au sein du sujet. Les conditions de nicotine (5 %, 3 %) ou (0 %, 5 %) x 2 fois (pré-post) sont les facteurs intra-sujets.
Par conséquent, l'étude est divisée en 2 parties, la première partie sera 2x2 comparant NJOY 5% et 3% pour tester les effets de la réduction partielle de la nicotine, et la deuxième partie utilisera la cigarette électronique de recherche standardisée NIDA (SREC) pour Recherche clinique 5% et 0% (placebo), pour tester l'effet de la réduction totale en utilisant les mêmes dosettes et jus du même fabricant.
Les enquêteurs émettent l'hypothèse que la NR sera associée à moins de satisfaction, de suppression du sevrage et d'intention d'utilisation et qu'un tel effet sera plus prononcé au total par rapport à la NR partielle et parmi les utilisateurs à forte dépendance par rapport aux utilisateurs à faible dépendance. Les études proposées visent à répondre à 3 questions réglementaires principales : 1) la NR est-elle une option réglementaire prometteuse pour réduire la dépendance et l'utilisation des ENDS ; 2) quel est l'effet du NR partiel par rapport au total sur les bouffées compensatoires et l'exposition à la nicotine et aux toxiques respiratoires, et 3) quel est l'effet du NR sur les utilisateurs d'ENDS à différentes étapes de leur utilisation. Combinées, ces études fourniront des preuves directes et standardisées sur le potentiel des réglementations NR pour limiter la dépendance et l'utilisation des ENDS, et pour aider à prédire les effets secondaires potentiels des NR sur l'exposition des utilisateurs d'ENDS à des substances toxiques nocives.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Florida
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Miami, Florida, États-Unis, 33199
- Florida International University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
- Individus généralement en bonne santé (déterminés par un examen physique).
- Âge de 21-35 ans.
- Est prêt à donner son consentement éclairé.
- Est disposé à assister au laboratoire comme l'exige le protocole d'étude.
- Utilisateurs de cigarettes électroniques (définis comme ayant utilisé la cigarette électronique quotidiennement ou occasionnellement au cours des 30 derniers jours)
- S'être abstenu d'utiliser la cigarette électronique pendant 12 heures avant chaque session
Critère d'exclusion:
- Déclarez fumer des cigarettes régulièrement (> 5 cigarettes/mois au cours de la dernière année).
- Déclarez l'utilisation régulière de tout autre produit du tabac/nicotine (par exemple, narguilé, pipes, cigares) au cours de l'année écoulée.
- Les femmes qui allaitent ou dont le test de grossesse est positif (par analyse d'urine lors du dépistage).
- Les personnes ayant des antécédents autodéclarés de maladie chronique ou de troubles psychiatriques actuels.
- Les personnes ayant des antécédents ou une maladie cardiovasculaire active, une pression artérielle basse ou élevée, des convulsions et l'utilisation régulière de médicaments sur ordonnance (autres que les vitamines ou le contrôle des naissances).
- Les personnes qui déclarent fumer/vapoter du THC (marijuana) actuellement.
- Les personnes qui signalent l'utilisation de liquide ou de produits de cigarette électronique non commerciaux (c'est-à-dire de rue)
- Les personnes qui signalent des symptômes actuels liés à EVALI ou au COVID-19 (c'est-à-dire toux, essoufflement, douleur thoracique, nausées, vomissements, douleur abdominale, diarrhée, fièvre, frissons ou perte de poids)
- Les personnes qui ont ou ont été exposées au COVID-19 au cours des 14 derniers jours.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Partial Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration
For the partial nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes.
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Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 5% nicotine concentration nicotine concentration
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Expérimental: Partial Nicotine Reduction: Electronic cigarette pods with 3% or 2.4% nicotine concentration
For the partial nicotine reduction study, participants will complete a lab visit where they will use 3% or 2.4% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes.
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Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 3% or 2.4% nicotine concentration
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Expérimental: Total Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration
For the total nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes.
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Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 5% nicotine concentration
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Expérimental: Total Nicotine Reduction: Electronic cigarette pods with 0% nicotine concentration
For the total nicotine reduction study, participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes.
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Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 0% nicotine concentration nicotine concentration
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Plasma Nicotine Boost
Délai: During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
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Change in plasma nicotine level.
The plasma nicotine boost was calculated by subtracting the preplasma nicotine value from the postplasma value.
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During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Puff Topography (Total Puffing Time)
Délai: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior in total puffing time
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Average Puff Duration)
Délai: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior in average puffing duration
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Puff Number)
Délai: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior; mean of the number of puffs taken during the ad-libitum smoking session
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Inhaled Volume)
Délai: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior; mean volume of puffs inhaled during the ad-libitum smoking session
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Toxicants (Carcinogenic and Probably or Possibly Carcinogenic) Exposure
Délai: During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants.
The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN).
The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis.
The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis.
ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
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During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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TPM (Total Particular Matter) Exposure
Délai: During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants.
The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN).
The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis.
The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis.
ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
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During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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Lung Function Tests (LFTs) Change
Délai: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use.
According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., change in FVC and FEV1) will be performed.
Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
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During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Lung Function Tests (LFTs) (% Predicted Change)
Délai: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use.
According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., % predicted value pred (FVC), FEV1 % pred FEV1/FVC, % pred) will be performed.
Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
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During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Minnesota Nicotine Withdrawal Scale (MNWS)
Délai: During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Nicotine withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS) before and after each vaping session.
MNWS evaluates 11 withdrawal-related symptoms, including depressed mood, irritability, restlessness, hunger, and difficulty concentrating, using scale from "0" (not at all) to "100" (extremely).
For each session and condition, change scores were calculated by subtracting pre-session from post-session scores for each individual item
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During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Tiffany-Drobes Questionnaire of Smoking Urges (QSU)
Délai: During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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The Tiffany-Drobes Questionnaire of Smoking Urges-Brief (QSU-Brief) is a 10-item self-report measure of cigarette craving and urge to smoke. It consists of two subscales representing distinct dimensions of craving: Factor 1 (Desire and Intention to Smoke): assesses desire, intention, and anticipation of pleasure associated with smoking. Factor 2 (Anticipation of Relief from Negative Affect and Withdrawal): assesses expectations that smoking will relieve withdrawal symptoms or negative affect. Each item is rated on a 7-point Likert scale ranging from 1 = strongly disagree to 7 = strongly agree. Subscale scores were calculated by averaging the items within each factor. Higher scores on either factor indicate greater smoking urge or craving, representing a worse outcome, whereas lower scores indicate lower craving or urge to smoke, representing a better outcome. Pre- to post-session change scores were calculated as pre-session score minus post-session score for each factor. |
During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Duke Sensory Questionnaire (DSQ)
Délai: During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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This scale will 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).
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During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Modified Cigarette Evaluation Questionnaire (mCEQ)
Délai: During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Modified Cigarette Evaluation Questionnaire (mCEQ) is used to assess subjective effects associated with ENDS use. The 11-item questionnaire evaluates satisfaction, psychological reward, enjoyment of respiratory tract sensations, craving reduction and aversion. Individual item scores were reported (not subscales). Each item was rated using 7-point Likert scale; 1 = not at all to 7 = extremely. For all items, higher scores indicate greater endorsement of the measured subjective experience, while lower scores indicate less endorsement of that experience. The interpretation depends on the construct being measured: For items assessing satisfaction, enjoyment, psychological reward, sensory experiences, and craving reduction, higher scores indicate greater product reinforcement or abuse liability. For items assessing aversion, higher scores indicate greater unpleasant effects or product aversiveness. |
During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Visual Analogue Scale (VAS)
Délai: During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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This scale contains 10-item questions to assess users' pleasure and enjoyment using the validated Visual Analog Scale (VAS) post ENDS use sessions.
The scale includes items to assess user's desire, pleasure, satisfaction, future use, and other information rated on an analog scale (0 not at all to 100 extremely).
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During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart Rate
Délai: During participants' 2 study visits. Heat rate will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in heart rate, measured in beats per minute (bpm).
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During participants' 2 study visits. Heat rate will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Blood Pressure (Systolic)
Délai: During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in systolic blood pressure, measured in mm/hg.
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During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Blood Pressure (Diastolic)
Délai: During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in diastolic blood pressure, measured in mm/hg.
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During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wasim Maziak, PhD, MD, Florida International University
Publications et liens utiles
Publications générales
- Ferdous T, Roy S, Chowdhury S, Jebai R, Maya L, DeCaprio AP, Bursac Z, Maziak W. Partial Nicotine Reduction and E-Cigarette Users' Puffing Behaviors Among Adults Aged 21 to 35 Years: A Randomized Crossover Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422954. doi: 10.1001/jamanetworkopen.2024.22954.
- Roy S, Chowdhury S, Ferdous T, Shihadeh A, Salman R, El Hage R, Salam S, Bursac Z, Maziak W. Predicting nicotine emissions and plasma nicotine boost in E-cigarette users using machine learning. Sci Rep. 2026 Jun 13. doi: 10.1038/s41598-026-57341-4. Online ahead of print.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01DA053587 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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