Avaliar a influência do fluxo de nicotina e da forma da nicotina nos efeitos subjetivos relacionados à dependência
24 de agosto de 2026 atualizado por: American University of Beirut Medical Center
Fluxo de nicotina, uma ferramenta potencialmente poderosa para regular a entrega de nicotina de cigarros eletrônicos: Significado do fluxo de nicotina para a taxa de entrega de nicotina e efeito subjetivo
Os sistemas eletrônicos de administração de nicotina (ENDS) aquecem e vaporizam um líquido contendo nicotina para produzir um aerossol que pode fornecer nicotina ao sangue e ao cérebro.
O uso de ENDS aumentou rapidamente na última década, especialmente entre os jovens: mais de 20% dos alunos do ensino médio nos EUA são usuários atuais de ENDS e há evidências de dependência de nicotina nessa população.
Foi proposta uma legislação federal que restringiria a concentração de nicotina líquida do ENDS para torná-lo "significativamente menos viciante e atraente para os jovens".
No entanto, é improvável que esses e outros esforços para reduzir o vício limitando a concentração líquida de nicotina tenham sucesso porque as emissões de nicotina do ENDS dependem de múltiplas variáveis.
Para alcançar os objetivos de saúde pública pretendidos, os regulamentos que visam o vício devem se concentrar na entrega de nicotina, não na concentração de nicotina.
Embora a entrega de nicotina não possa ser regulada diretamente, a taxa na qual um ENDS emite nicotina, o "fluxo de nicotina", pode ser regulada e, principalmente, prevista com base em algumas variáveis de design e operação do dispositivo.
No entanto, até o momento não há evidências empíricas que demonstrem a relação entre fluxo e entrega, nem entre fluxo e os efeitos subjetivos que sustentam a dependência da nicotina.
Fechar essa lacuna é essencial para fornecer uma estrutura eficaz para regulamentar os ENDS.
Na Universidade Americana de Beirute, os pesquisadores avaliarão a relação entre o fluxo, a forma e os efeitos subjetivos da nicotina.
Os participantes usarão dispositivos ENDS com diferentes fluxos e formas de nicotina.
Medidas de dependência, como desejo de fumar, desejo e abstinência, serão avaliadas.
O resultado indicará o grau em que o fluxo/forma da nicotina influencia os efeitos subjetivos relacionados à dependência, intensidade da tragada e exposição a substâncias tóxicas.
Em resumo, este projeto fornecerá as evidências empíricas necessárias para que as agências de saúde pública usem o fluxo de nicotina como uma construção abrangente e conveniente para regular a liberação de nicotina dos ENDS.
Visão geral do estudo
Status
Concluído
Descrição detalhada
Avalie a influência do fluxo de nicotina e da forma da nicotina nos efeitos subjetivos.
No AUB, os investigadores avaliarão os efeitos subjetivos (por exemplo,
gosto do produto, desejo de nicotina) e topografia de sopro para 130 participantes que serão submetidos a 5 sessões de uso de ENDS consistindo em 2 sessões (10 sopros + 60min ad libitum) com 2 fluxos (16 e 32μg/s) x 2 formas (protonadas, freebase) e uma condição de 0 nicotina.
Além disso, os investigadores usarão um dispositivo de última geração para amostrar in situ uma fração do aerossol gerado durante cada sopro para verificar o fluxo e a forma reais da nicotina e medir a exposição a substâncias tóxicas pulmonares (carbonilas).
Os investigadores levantam a hipótese de que o aumento do fluxo de nicotina e da nicotina protonada resultará em maiores reduções do desejo de nicotina e menor intensidade de tragada e exposição ao carbonil.
Tipo de estudo
Intervencional
Inscrição (Real)
142
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Beirut
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Beirut, Beirut, Líbano, 11-0236
- American University of Beirut
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Descrição
Critério de inclusão:
- Deve ser saudável e ter mais de 18 anos
- Deve estar disposto a fornecer consentimento informado, comparecer ao laboratório e abster-se de tabaco/nicotina conforme necessário (os participantes serão instruídos a abster-se de nicotina/tabaco e/ou uso de ENDS por ≥12h)
- Um SEAN duplo e usuário de tabaco que relata uso diário de SEAN (≥ 3 mg/ml de nicotina) ou cigarros (qualquer frequência) E uso algum dia (≥ 3 dias/semana) de SEAN (≥ 3 mg/ml de nicotina) ou cigarros (qualquer frequência) nos últimos 3 meses ou mais
Critério de exclusão:
- História de doença crônica ou condição psiquiátrica descontrolada
- Histórico ou doença cardiovascular ativa, pressão arterial baixa/alta, convulsões, uso regular de medicamentos prescritos (exceto vitaminas/anticoncepcionais)
- Uso de cocaína, opioides, benzodiazepínicos ou metanfetaminas no último mês
- Indivíduos que relatam uso de maconha >15/30 dias
- As mulheres serão excluídas se estiverem amamentando ou grávidas
- Participantes com intenção de parar de fumar/nicotina nos próximos 30 dias e encaminhados para tratamento de cessação
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Placebo - Combinação Cinco - 0μg/s de fluxo de nicotina
Os investigadores testarão os efeitos subjetivos do placebo de fluxo de nicotina (0μg/s).
Após um período de observação de uma hora, os participantes usarão o Subox Mini C em uma sessão de 10 puffs direcionados (30 segundos de intervalo entre os puffs).
Uma hora após a primeira sessão, os participantes serão instruídos a soprar no aparelho por 60 minutos ad libitum.
Medidas subjetivas (ou seja, dependência de nicotina, efeitos de drogas, gosto pelo produto e desejo) serão administradas 5 vezes/sessão: 5 min antes e 5 min após o início da sessão direcionada e 5 min antes, na metade e 5 min após o início da sessão o ataque ad libitum.
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Proporção 30/70 PG/VG com concentração de nicotina 0mg/ml (placebo)
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Experimental: Combination One - 15μg/s protonated nicotine flux
The investigators will test the subjective effects of nicotine flux (15μg/s) coupled with one ratio of nicotine form (100% protonated).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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30/70 propylene glycol/vegetable glycerin ratio with nicotine concentration 4mg/ml protonated
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Experimental: Combination Two - 35μg/s protonated nicotine flux
The investigators will test the subjective effects of nicotine flux (35μg/s) coupled with one ratio of nicotine form (100% protonated).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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Relação 30/70 PG/VG com concentração de nicotina 10mg/ml protonada
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Experimental: Combination Three - 15μg/s free base nicotine flux
The investigators will test the subjective effects of nicotine flux (15μg/s) coupled with one ratio of nicotine form (100% free base).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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Proporção 30/70 PG/VG com concentração de nicotina 4mg/ml base livre
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Experimental: Combination Four - 35μg/s free base nicotine flux
The investigators will test the subjective effects of nicotine flux (35μg/s) coupled with one ratio of nicotine form (100% free base).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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Proporção 30/70 PG/VG com concentração de nicotina 10mg/ml base livre
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Experimental: Combination six - 0μg/s flux; high power/low power
The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two power levels (20W and 40 W) with no nicotine in the liquid.
Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices differing only by the two power levels.
Subjective measures will be administered following puff pairs 1&2, 5&6, and 9&10.
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Razão 30/70 PG/VG com concentração de nicotina 0mg/ml
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Experimental: Combination seven - 35μg/s flux; high power/low power
The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two power levels (20W and 40 W) and a constant nicotine flux of 35 ug/s.
Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices (20 W; 8mg/ml and 40 W;4 mg/ml).
Subjective measures will be administered following puff pairs 1&2, 5&6, and 9&10.
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e-líquido 7: 30/70 PG/VG RAZO com concentração de nicotina 4mg/ml Protonado e-líquido 8: 30/70 pg/vg com concentração de nicotina 8mg/ml Protonado
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Experimental: Combination eight - 15μg/s flux; high PG(propylene glycol)/VG(vegetable glycerin) / low PG/VG
The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two propylene glycol/vegetable glycerin ratios (30/70 and 70/30).
Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices differing only by the two PG/VG ratios.
Subjective measures will be administered following puff pairs 1&2, 5&6, and 9&10.
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e-líquido 9: 30/70 PG/VG com concentração de nicotina 4mg/ml protonada e-líquido 10: 70/30 pg/vg com concentração de nicotina 4mg/ml protonada
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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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Subjective Effects - Strong Flavor (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Strong flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger perceived flavor.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Harshness/Irritancy (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Harshness/irritancy will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating harsher/more irritating effects.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Throat Hit (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger throat hit.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Flavor (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the flavor was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Harshness (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: harshness will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the harshness was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Throat Hit (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the throat hit was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Warmth (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: warmth will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the warmth was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Satisfying (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Satisfying will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater satisfaction.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Pleasant (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Pleasant will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater pleasantness.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Taste Good (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Taste good will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better taste.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Calm (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Calm will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling calmer.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Concentrate (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Concentrate will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better ability to concentrate.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Awake (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Awake will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more awake/alert.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Reduce Hunger (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Reduce hunger will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater reduction in hunger.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Dizzy (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Dizzy will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater dizziness.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Feeling Sick (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Feeling sick will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more sick.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Want it Right Now (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Want it right now will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger immediate desire for the product.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Smell (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Smell will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger perceived smell.
This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS.
Participants rate the item on a 0-10 scale immediately following each bout.
Item wording: 'Did the e-cig produce a smell?' (0 = not at all, 10 = extremely).
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Visible Vapor (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Visible vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating more visible vapor.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Importance Vapor (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Importance vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating vapor visibility mattered more to the participant.
This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS.
Participants rate the item on a 0-10 scale immediately following each bout.
Item wording: 'Is the vapor/cloud of the e-cig important to you?' (0 = not at all, 10 = extremely).
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Puffs Similar (Combinations 1-5)
Prazo: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Puffs similar will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating the puffs were perceived as more similar to the participant's usual product.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Smoking Urges - Brief Factor 1 (Intention/Desire)
Prazo: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Brief Factor 1 (Intention/Desire) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany & Drobes, 1991; Toll et al., 2006).
Factor 1 is the sum of 6 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-60, with higher scores indicating stronger urges.
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Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Smoking Urges - Brief Factor 2 (Relief of Neg. Affect)
Prazo: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Brief Factor 2 (Relief of Neg.
Affect) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany & Drobes, 1991; Toll et al., 2006).
Factor 2 is the sum of 4 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-40, with higher scores indicating stronger urges.
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Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Withdrawal Symptoms - Minnesota Nicotine Withdrawal Scale (MNWS; Based on Hughes and Hatsukami, 1986)
Prazo: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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The Minnesota Nicotine Withdrawal Scale (MNWS; based on Hughes and Hatsukami, 1986 questionnaire) was measured using composite mean of MNWS items (irritability, anxiety, difficulty concentrating, restlessness, hunger/appetite, Impatient, depression, desire for sweets and craving) on a 0-10 scale (Not at all - Extremely), with higher scores indicating greater withdrawal severity.
|
Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Puff Duration
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Puff duration combination 1,2,3,4 & 5
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Number of Puffs
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Total Number of Puffs (puffs).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Puffing Time
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Average Puffing time (sec).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Inter Puff Interval
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Average Inter Puff Interval (sec).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Flow Rate
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Average Flow rate (Liters per minute: LPM).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Mouth-level PM
Prazo: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Mouth-level PM (Particulate matter) dose estimated using the REALTIME real-time in-situ sampling device, which collects 5% of the aerosol at the mouthpiece during each puff; values are reported as the total session dose (5% fraction × 20), in mg.
|
Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Mouth-level Nicotine
Prazo: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Mouth-level nicotine dose estimated using the REALTIME real-time in-situ sampling device, which collects 5% of the aerosol at the mouthpiece during each puff; values are reported as the total session dose (5% fraction × 20), in mg.
|
Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Puff Duration - Combination 6,7 & 8
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout
|
Measured topography Average Puff Duration (sec) - using Subox mini C. Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
|
Sensory Feedback - Perceived Mouthful - Using Kangertech Subox Mini C (Sub-ohm Device)
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout
|
The perceived mouthful will be assessed using the following question: "How would you rate the amount of smoke filling your mouth during the puff you just smoked?".
A subjective visual analog scale will be used (1-5, barely any smoke- a lot of smoke) with higher scores indicating higher mouthful.
Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
|
Sensory Feedback - Perceived Draw Effort - Using Kangertech Subox Mini C (Sub-ohm Device)
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout
|
The perceived draw effort will be assessed using the following question: " How would you rate the effort needed to draw the puff you just smoked?".
A subjective visual analog scale will be used (1-5, easy- hard) with higher scores indicating harder draw effort.
Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
|
Sensory Feedback - Throat Hit - Using Kangertech Subox Mini C (Sub-ohm Device)
Prazo: Will be measured during the approximately 5-minute, 10-puff use bout
|
The perceived Throat hit will be assessed using the following question: "How would you describe the throat hit of the device you just used" (0-100 General Labeled Magnitude Scale; anchors: "barely detectable" to "strongest imaginable").
Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Soha Talih, PhD, American University of Beirut Medical Center
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
13 de julho de 2022
Conclusão Primária (Real)
11 de julho de 2025
Conclusão do estudo (Real)
11 de julho de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
8 de junho de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de junho de 2022
Primeira postagem (Real)
24 de junho de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de agosto de 2026
Última verificação
1 de fevereiro de 2025
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- American University Of Beirut
- 1R01DA052565-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Os dados dos participantes não estarão disponíveis para outros pesquisadores
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .