Completado

SKY PilotAcute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Charcoal-filtered cigarette

+ Non-charcoal filtered cigarette

Otro
Quiénes están siendo reclutados

De 21 a 60 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: marzo de 2022
Ver detalles del protocolo

Resumen

Patrocinador PrincipalAbramson Cancer Center at Penn Medicine
Última actualización: 13 de diciembre de 2025
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 10 de marzo de 2022

Fecha en la que se inscribió al primer participante.

We will recruit 40 adult daily, non-menthol smokers to a single 2-hr laboratory study where they will smoke two study-provided \[commercially available\] cigarettes, each for a 10-min ad lib period, and then complete product perception and use measures. Smoking sessions will be video recorded and scored to capture puffing behavior, and carbon monoxide (CO) assessments will be collected before and after smoking to assess changes in acute smoke exposure. We will use a 2 x 2 mixed factorial design to manipulate the study-provided cigarette's packaging (between subject factor: light colored 'Sky' package vs. black NAS package; both industry-made) and filter type (within-subject factor: charcoal filter vs. non-charcoal filter; cigarettes will appear identical despite differences in filter composition). Primary outcomes will be product perceptions (risk perceptions, subjective ratings), use behaviors (puffing behavior and purchase task), and acute toxicant exposure (changes in CO).

Título OficialAcute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure 
NCT05157048
Patrocinador PrincipalAbramson Cancer Center at Penn Medicine
Última actualización: 13 de diciembre de 2025
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 42 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 21 a 60 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.

Criterios

Inclusion Criteria: * Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months. * Smokers of primarily non-menthol cigarettes. * Not currently undergoing smoking cessation treatment or trying to quit. * Able to communicate fluently in English (speaking, writing, and reading). * Capable of giving written informed consent. Exclusion Criteria: Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study: Smoking Behavior 1. Use of menthol cigarettes as preferred/regular brand (defined as using \>20% of the time). 2. Use of research cigarettes in the past 6 months (i.e., past 6-month participation in applicable previous CIRNA studies). 3. Enrollment or plans to enroll in a smoking cessation program in the next month. 4. Provide an initial Carbon Monoxide (CO) reading \< 5 parts per million (ppm). Alcohol/Drugs 1. History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. 2. Current alcohol consumption that exceeds 25 standard drinks/week. Medical 1. Women who are pregnant, planning a pregnancy, and/or lactating. 2. Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the PI and eligibility will be determined on a case-by-case basis. 3. Color blindness. 4. Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis. Psychiatric As determined by self-report: 1. Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia. 2. Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible. Other Additionally, participants may be deemed ineligible for any of the following general reasons at any point throughout the study, as well as during the initial telephone screen, at the discretion of the PI: * Significant non-compliance with protocol and/or study design. * Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact study data. * Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Participants will be randomized to one of two pack color conditions: light or dark. Those in the dark pack color condition will be given Natural American Spirit Black packs.

Grupo II

Experimental
Participants will be randomized to one of two pack color conditions: light or dark. Those in the light pack color condition will be given Natural American Spirit Sky packs.

Objetivos 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

Suspendido

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, United StatesVer ubicación
Completado1 Centros de Estudio