Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
very low nicotine content cigarettes
+ Study e-cigarette
+ normal nicotine content cigarettes
Troubles Mentaux+1
+ Trouble de l'usage du tabac
+ Troubles liés aux substances
Autre étude
Résumé
Date de début de l'étude : 12 octobre 2022
Date à laquelle le premier participant a commencé l'étude.Participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. During the screening session, participants will also be asked to complete surveys. Eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. During the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. They will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. The 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.7 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 21 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 1. Legal age to purchase tobacco products; 2. Regular user of EC and CC; 3. Owns the e-cigarette device used most often; 4. Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session; 5. Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid Exclusion Criteria: 1. Unstable medical conditions as determined by the licensed medical professional; 2. Unstable psychiatric conditions as determined by the licensed medical professional or PI; 3. Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy; 4. Serious quit attempt of either or both products in the past 3 months resulting in \>30 days of abstinence; 5. Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide; 6. Plans to quit use of either EC or CC, or all tobacco products in the next 45 days; 7. Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid; 8. Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): 1. Systolic blood pressure (BP) greater than or equal to 160 mm/hg 2. Diastolic BP greater than or equal to 100 mm/hg 3. Heart rate greater than or equal to 115 bpm; 9. Allergy to propylene glycol or vegetable glycerin; 10. Previous adverse reaction when using vaping device or e-liquid; 11. Current or recent alcohol or drug abuse problems; 12. Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months; 13. Literate and able to independently complete and comprehend the consent form and other written study materials and measures.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifGroupe III
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Duke University Medical Center
Durham, United StatesOuvrir Duke University Medical Center dans Google Maps