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El ensayo clínico NCT06372899 para Uso de cigarrillo electrónico, Tabaquismo, Reducción de daños, Consumo de tabaco está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Centro Oncológico AbramsonNoncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers 200 Basado en biomarcadores Aleatorizado
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El ensayo clínico NCT06372899 es un estudio intervencionista para Uso de cigarrillo electrónico, Tabaquismo, Reducción de daños, Consumo de tabaco. Su estado actual es: reclutando. El estudio se inició el 2 de octubre de 2024, con el objetivo de reclutar a 200 participantes. Dirigido por el Centro Oncológico Abramson, se espera que finalice el 31 de marzo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 12 de marzo de 2026.
Resumen
This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be ...Mostrar más
Descripción detallada
E-cigarettes (ECIGS), and oral nicotine pouches (ONPs), expose users to few of the chemicals found in cigarette smoke and are thus promising noncombustible harm reduction tools for smokers who would not otherwise quit smoking. For their harm reduction potential to be realized, fundamental questions must be answered. One, can persistent smokers switch from combustible cigarettes to either ECIGS or ONPS? Two, what fact...Mostrar más
Título oficial
Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
Condiciones médicas
Uso de cigarrillo electrónicoTabaquismoReducción de dañosConsumo de tabacoOtros ID del estudio
- UPCC 02024
- R01CA290541-01A1 (Subvención/contrato NIH (EE. UU.))
- 855140 (Otro identificador) (University of Pennsylvania IRB Protocol Number)
Número del NCT
Inicio del estudio (real)
2024-10-02
Última actualización
2026-03-12
Fecha de finalización (estimada)
2028-03-31
Inscripción (prevista)
200
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Objetivo principal
Ciencia básica
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalECIGS Participants randomized to ECIGS will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study-provided e-cigarette device. Participants will be able to choose between Tobacco, Menthol, Watermelon, and Blueberry flavored nicotine pods. They will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior. | Cigarrillos electrónicos Participants randomized to ECIGS are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. They will be provided with an e-cigarette device and nicotine pods. |
ExperimentalONPS Participants randomized to ONPS will be provided with oral nicotine pouches and be instructed to switch from smoking combustible cigarettes to using only the study-provided nicotine pouches. Participants will be able to choose between Original, Mint, Berry, and Citrus flavored nicotine pouches. They will receive their supply of nicotine pouches in 7-day increments, based on baseline smoking behavior. | Oral nicotine pouches Participants randomized to ONPS are instructed to switch from smoking combustible cigarettes to using nicotine pouches for 6 weeks. They will be provided with nicotine pouches. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Cigarette Consumption | The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the switch phase. Daily cigarette consumption will be determined by counting the daily spent cigarette filters returned for each of the 42 days (days 8 - 49). | 42 days (days 8 - 49) |
Cigarette Smoking Across Follow-Up | Average cigarettes per day at the 6-month follow-up is a secondary endpoint, measured by the valid and reliable timeline follow-back (TLFB) interview. | 19 Weeks (Day 50-6-Month Follow-Up) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Biomarkers of Exposure: Carbon Monoxide (CO) | Carbon Monoxide (CO) will be measured using a CO monitor. A CO \> 5 ppm indicates combustible cigarette smoking. | 49 days (days 1-49) |
Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%) | The mean mid-expiratory forced expiratory flow (FEF25% - 75%) is a measure of lung function and inflammation. FEF25% - 75% will be assessed using spirometry according to the American Thoracic Guidelines. | 49 days (days 1-49) |
Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) | 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) is a primary nitrosamine marker of tobacco exposure and an often-used indicator of carcinogen exposure. NNAL will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine). | 49 days (days 1-49) |
Biomarkers of Exposure:1-hydroxypyrene (1-HOP) | 1-hydroxypyrene (1-HOP) is a widely used biomarker of carcinogenic polycyclic aromatic hydrocarbon exposure. 1-HOP will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine). | 49 days (days 1-49) |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
21 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- Able to communicate fluently in English (i.e. speaking, writing, and reading)
- Male and female smokers who are > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
- Have a carbon monoxide (CO) greater than 10 ppm.
- Not using any forms of nicotine regularly other than cigarettes
- Be willing to switch to e-cigarettes or nicotine pouches for 6 weeks.
- Plan to live in the area for the duration of the study.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Smoking Behavior
Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette and nicotine pouch use is defined as greater than 5 days/past 30 days.
a. Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered eligible.
Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
Current use of smoking cessation medication
Provide a CO breath test reading less than 10 ppm at Intake.
Alcohol and Drug
- History of substance abuse (other than nicotine dependence) in the past 12 months.
- Current alcohol consumption that exceeds 20 standard drinks/week.
- Current use of recreational drugs (other than nicotine and cannabis)
- Breath alcohol reading (BrAC) greater than .000 at Intake.
Medical
- Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
- Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
Psychiatric
1. Lifetime history of schizophrenia or psychosis.
General Exclusion
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator.
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator. Subjects may be deemed ineligible at any point throughout the study.
Centro Oncológico Abramson- Instituto Nacional del Corazón, los Pulmones y la Sangre, Estados Unidos3019 estudios activos para explorar
- Universidad de Pensilvania503 estudios activos para explorar
Parte responsable del estudio
Janet E. Audrain-McGovern, PhD, Investigador principal, Professor, University of Pennsylvania
Contactos centrales del estudio
Contacto: Janet Audrain-McGovern, Ph.D., 215-746-7145, [email protected]
1 Centros del estudio en 1 países
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Janet Audrain-McGovern, Ph.D., Contacto, 215-746-7145, [email protected]
Reclutando