- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03111537
Methods Project 4: Clinical Trial - Amended (COMET)
Project 4: Clinical Trial Method for Assessing a Tobacco Product Part of Models for Tobacco Product Evaluation:
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sampling period (1 week): Subjects will be randomized to an alternative nicotine product (E-cigarette, Nicotine Gum or Lozenge) or assigned to continue smoking their usual brand cigarettes. Subjects will complete screening assessments, asked to sample the assigned product and start recording their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Smokers assigned to the control condition (smoking usual brand cigarettes) will be asked to choose the product that they would like to sample.
Baseline smoking period: After sampling, subjects who meet specific criteria will continue with the experimental intervention phase. These subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured. Records of their cigarette or other tobacco intake on a daily basis will continue using the interactive voice response system (IVR).
Experimental Period: After the baseline assessment, subjects will be instructed to either partially or completely substitute their cigarette smoking with their assigned product. They will assigned to one of six experimental conditions:
- smoking usual brand cigarette controls, who after 8-weeks will be offered any of the other nicotine products to use as they choose for 8 weeks;
- complete substitution (i.e., no smoking) with an E-cigarette;
- partial substitution with an E-cigarette;
- complete substitution (i.e., no smoking) with nicotine gum or nicotine lozenge.
The assigned product, E-cigarette, Nic Gum or Lozenge, but not usual brand cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55455
- Masonic Cancer Center, University of Minnesota
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-
New York
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Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Center
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female subjects who are at least 18 years of age;
- Daily smoker;
- Generally good health;
- Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);
Exclusion Criteria:
- Unstable health;
- Pregnant or breastfeeding (due to toxic effects from tobacco products);
- Unable to read for comprehension or completion of study documents.
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: Usual Brand Cigarette
Smoking usual brand cigarette controls, who after 8-weeks will be offered alternative nicotine products and instructed for partial or complete substitution of cigarettes (subject's choice);
|
Fuman su marca habitual de cigarrillos y siguen sus patrones normales de uso.
|
Experimental: Complete Substitution E-Cigarette
Complete substitution (i.e., no smoking) with e-cigarette use
|
Use of E-cigarette: multiple flavors offered.
|
Experimental: Partial Substitution E-Cigarette
Partial substitution, encouraged to use e-cigarettes instead of smoking usual cigarettes
|
Fuman su marca habitual de cigarrillos y siguen sus patrones normales de uso.
Use of E-cigarette: multiple flavors offered.
|
Experimental: Complete Substitution Nic Gum or Lozenge
Complete substitution (i.e., no smoking) to nicotine gum or lozenge use
|
Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Periodo de tiempo: 6 months
|
Compare the exposure to nicotine in the two instructions for use arms (complete substitution vs. partial substitution) across study products and compared to medicinal nicotine products and usual brand cigarettes.
|
6 months
|
Determine stabilization of product use (e.g., cigarette, oral tobacco, e-cigarette or medicinal nicotine patterns of use).
Periodo de tiempo: 6 months
|
Examining time effects for patterns of use of cigarettes, nicotine replacement, oral tobacco or e-cigarette.
|
6 months
|
Consumer perception of the product and response to the product after sampling.
Periodo de tiempo: 6 months
|
Consumer perception of the product evidenced by choice of which product to use in the trial after sampling.
|
6 months
|
Compare NNK exposure based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Periodo de tiempo: 8 weeks
|
Complete substitution vs. partial substitution of study products for cigarettes and compare the exposure to NNK by analyzing NNAL levels in subject urine.
These products are compared to medicinal nicotine products and usual brand cigarettes.
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2012NTLS050b
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