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
Trastornos Mentales
+ Trastorno por uso de tabaco
Otro tipo de estudio
Resumen
Fecha de inicio: 12 de octubre de 2022
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 7 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro Tipo de Estudio
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 21 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoGrupo III
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Duke University Medical Center
Durham, United StatesAbrir Duke University Medical Center en Google Maps