Methods Project 4: Clinical Trial - Amended (COMET)
Project 4: Clinical Trial Method for Assessing a Tobacco Product Part of Models for Tobacco Product Evaluation:
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Minnesota
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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);
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Fume sua marca habitual de cigarros e siga seus padrões normais de uso.
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Experimental: Complete Substitution E-Cigarette
Complete substitution (i.e., no smoking) with e-cigarette use
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Use of E-cigarette: multiple flavors offered.
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Experimental: Partial Substitution E-Cigarette
Partial substitution, encouraged to use e-cigarettes instead of smoking usual cigarettes
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Fume sua marca habitual de cigarros e siga seus padrões normais de uso.
Use of E-cigarette: multiple flavors offered.
|
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Experimental: Complete Substitution Nic Gum or Lozenge
Complete substitution (i.e., no smoking) to nicotine gum or lozenge use
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Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Prazo: 6 months
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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.
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6 months
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Determine stabilization of product use (e.g., cigarette, oral tobacco, e-cigarette or medicinal nicotine patterns of use).
Prazo: 6 months
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Examining time effects for patterns of use of cigarettes, nicotine replacement, oral tobacco or e-cigarette.
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6 months
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Consumer perception of the product and response to the product after sampling.
Prazo: 6 months
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Consumer perception of the product evidenced by choice of which product to use in the trial after sampling.
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6 months
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Compare NNK exposure based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Prazo: 8 weeks
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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.
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2012NTLS050b
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