- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03294356
CSD170304: Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes
CSD170304: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Arizona
-
Tempe, Arizona, Estados Unidos, 85283
- Clinical Research Consortium (CRC)
-
-
Kentucky
-
Lexington, Kentucky, Estados Unidos, 40509
- Central Kentucky Research Associates (CKRA)
-
-
Missouri
-
Saint Louis, Missouri, Estados Unidos, 63141
- St. Louis Clinical Trials (SLCT)
-
-
Ohio
-
Dayton, Ohio, Estados Unidos, 45417
- Midwest Clinical Research (MCRC)
-
-
Tennessee
-
Knoxville, Tennessee, Estados Unidos, 37920
- New Orleans Center for Clinical Research (NOCCR)
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit.
Subjects must meet one (a or b) of the following tobacco use conditions:
- Exclusive cigarette smoker who self-reports smoking ≥ 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation will be allowed at the discretion of the Principal Investigator (PI).
- Dual user of CCs and ECs who self-reports:
i. Smoking ≥ 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation will be allowed at the discretion of the PI; and ii. Using a nicotine-containing "cig-a-like" EC or a tank system EC either daily or at least weekly for at least 3 months prior to Screening Visit.
- Willing to be confined overnight and abstain from tobacco- and nicotine-containing product use (with the exception of study IP use) for 12 hours prior to IP use through Study Discharge.
- Willing to use assigned IP during the study according to protocol.
- Expired breath carbon monoxide (ECO) level is ≥ 10 parts per million (ppm) at the Screening Visit and Study Day 1.
- Positive urine cotinine test at the Screening Visit and Study Day 1.
- No intent to quit smoking or vaping from Screening to Study Day 2.
- Females of childbearing age must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit.
Exclusion Criteria:
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical condition at the Screening Visit, as determined by the PI, that would preclude a subject from participating safely in the study (e.g.,, uncontrolled hypertension, chronic lung disease, cardiac disease, neurological disease, or psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations.
- At risk for heart disease, as determined by the PI.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for 5 minutes.
- Weight of ≤ 110 pounds.
- Poor peripheral venous access.
- Use of medicine for treatment of depression, unless on a stable dose for the past 6 months prior to screening and deemed clinically stable by the PI.
- Current on scheduled treatment(s) for asthma within the past consecutive 12 months prior to screening. If potential subject is on an as-needed treatment, such as rescue inhalers, subject may be included at the PI's discretion pending approval from the Medical Monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically or cryogenically removed.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract, within 30 days prior to the Screening Visit.
- History or presence of hemophilia or other bleeding disorders.
- History or presence of clotting disorders with concomitant use of anticoagulants (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®], aspirin [> 325 mg/day]).
- Participation in another clinical trial within 30 days prior to the time of consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of consent of the current study.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).
- Females who have a positive pregnancy test or who are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Females ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive urine drug screen without disclosure of prescribed corresponding concomitant medication(s) at the Screening Visit or on Study Day 1.
- A positive alcohol breathalyzer result at the Screening Visit or on Study Day 1.
- Employed by a tobacco or nicotine-manufacturing company, the study site, or handles tobacco or nicotine-containing products as part of their job.
- Determined by the PI to be inappropriate for the study, including a subject who is unable to communicate or unwilling to cooperate with the clinical staff.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: FT210771 Group
7 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period.
|
An electronic cigarette
|
Experimental: FT210751 Group
7 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period.
|
An electronic cigarette
|
Experimental: 6T30134157764 Group
7 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period.
|
An electronic cigarette
|
Experimental: G41A7C071 Group
7 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period.
|
An electronic cigarette
|
Experimental: M011161212 Group
7 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period.
|
An electronic cigarette
|
Experimental: FT21002 Group
7 day at-home use of combustible cigarette FT21002 followed by a 2 day in-clinic period.
|
A combustible cigarette
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cmax (Concentración plasmática máxima de nicotina ajustada al valor inicial)
Periodo de tiempo: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutos
|
Evaluar la absorción de nicotina con el inicio de un período de uso del producto en investigación (PI) ad libitum de 10 minutos.
|
-5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutos
|
AUCnic0-60
Periodo de tiempo: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutos
|
Área bajo la curva de concentración de nicotina versus tiempo ajustada a la línea de base desde el tiempo cero hasta 60 minutos después del inicio de un período de uso de IP ad libitum de 10 minutos.
|
-5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutos
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PGeneral
Periodo de tiempo: 13 minutos
|
El gusto general por el producto (PL) es una medida adicional de cuánto le gusta el producto al sujeto, y es indicativo de su posible disposición a buscar el uso del producto nuevamente en un momento posterior; medido 13 minutos después del inicio del uso de IP.
|
13 minutos
|
Tmax
Periodo de tiempo: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
|
Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.
|
-5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
|
AUCnic0-15
Periodo de tiempo: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
|
Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.
|
-5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Corey Anderson, MD, Clinical Research Consortium (CRC)
- Investigador principal: Mark Adams, MD, Central Kentucky Research Associates (CKRA)
- Investigador principal: Daniel Gruener, MD, St. Louis Clinical Trials (SLCT)
- Investigador principal: Otto Dueno, MD, Midwest Clinical Research (MCRC)
- Investigador principal: William Smith, MD, New Orleans Center for Clinical Research (NOCCR)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CSD170304
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .