Investigation of Cigarette Cravings in Smokers
11 de abril de 2021 atualizado por: Marco Leyton
Investigating Stress-Potentiated Memory Updating as a Novel Intervention for Non-Treatment Seeking Smokers
Interventions to disrupt memory reconsolidation have held promise for the treatment of stress- and anxiety-related disorders. In the present study, the investigators will examine whether an intervention based on these principles, called memory updating, could be adapted for reward-seeking behaviors. To test this, non-treatment seeking tobacco smokers will be exposed to smoking cues and/or stress, two stimuli known to trigger smoking. It is predicted that exposure to a stress task will enhance the cues' motivational salience and yield greater susceptibility to the memory updating procedure.
As an add-on, the investigators will examine COVID-associated changes in substance use and whether participants in the memory updating groups might be more resilient to these effects. It is predicted that the changes in substance use will depend on whether the substances are used primarily in social settings.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Descrição detalhada
Non-treatment seeking cigarette dependent smokers will be randomized to one of four testing conditions: 1) a non-stressful task followed by neutral cues, 2) the non-stressful task followed by smoking cues, 3) a stressful task followed by neutral cues, or 4) the stressful task followed by smoking cues. Ten minutes after the intervention, participants will undergo a 60-minute extinction procedure consisting of smoking-related videos, images and smoking paraphernalia. Cue reactivity test sessions will take place 24 hours, 2 weeks and 6 weeks following the intervention.
COVID-associated changes in substance use will be quantified over three telephone interviews: one at the end of March / beginning of April 2020 (at the start of the pandemic), one at the end of April / beginning of May, and a final one which will be instituted if feasible once the infection rates and social distancing policies have decreased.
Tipo de estudo
Intervencional
Inscrição (Real)
76
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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Quebec
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Montreal, Quebec, Canadá, H3A 1A1
- McGill University
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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 a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Scoring 5 or higher on the Fagerström Test for Cigarette Dependence
- Willingness to abstain from smoking for 4 hours prior to each laboratory visit
Exclusion Criteria:
- Currently using cigarette cessation products
- Endocrinological problems
- Significant mental or physical health conditions
- Pregnancy
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Stress task and smoking cue
Exposure to a psychosocial stress task followed by smoking video cues
|
Exposure to a psychosocial stressor
Exposure to a smoking-related task
|
|
Experimental: Stress task and neutral cue
Exposure to a psychosocial stress task followed by neutral video cues
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Exposure to a psychosocial stressor
Exposure to neutral cues
|
|
Comparador Ativo: Control task and smoking cue
Exposure to a control task followed by smoking video cues
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Exposure to a smoking-related task
Exposure to a control task (no stress)
|
|
Comparador Ativo: Control task and neutral cue
Exposure to a control task followed by neutral video cues
|
Exposure to neutral cues
Exposure to a control task (no stress)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
Prazo: At the end of test session 1 (24 hours post-intervention), participants will receive a journal to record their daily smoking behaviour. They are asked to keep this journal until test session 3 (6 weeks post-intervention).
|
A journal is given to participants to record their cigarette use behaviour every day for a month and a half
|
At the end of test session 1 (24 hours post-intervention), participants will receive a journal to record their daily smoking behaviour. They are asked to keep this journal until test session 3 (6 weeks post-intervention).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
Prazo: Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
|
Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions
|
Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
|
|
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 3
Prazo: Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
|
Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions
|
Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
|
|
Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 2
Prazo: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions
|
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
|
Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 3
Prazo: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions
|
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
|
Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 2
Prazo: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
Participants' skin conductance will be measured through the use of electrodes on their index and middle fingers at several time points during the study sessions
|
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
|
Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 3
Prazo: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
Participants' skin conductance will be measured through the use of electrodes on their index and middle fingers at several time points during the study sessions
|
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
|
Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to during COVID-19
Prazo: Multiple time points at baseline (before the pandemic), at the start of the pandemic, and during the pandemic
|
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
|
Multiple time points at baseline (before the pandemic), at the start of the pandemic, and during the pandemic
|
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Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to post-COVID-19
Prazo: At baseline (before the pandemic) and through study completion, an average of 1 year
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Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
|
At baseline (before the pandemic) and through study completion, an average of 1 year
|
|
Change in tobacco and other substance use patterns during the COVID-19 pandemic to post-COVID-19
Prazo: Multiple time points during the pandemic and through study completion, an average of 1 year
|
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
|
Multiple time points during the pandemic and through study completion, an average of 1 year
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
Prazo: Multiple time points during the intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
Participants will be asked to complete a mood questionnaire at several time points during the intervention and at test sessions 1, 2 and 3
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Multiple time points during the intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
|
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Change in cigarette use over the course of the procedure as a function of personality factors, childhood trauma, perceived stress, mood and/or cigarette withdrawal
Prazo: Multiple time points at baseline, during the intervention, at test sessions (24 hours, 2 weeks and 6 weeks post-intervention) and telephone follow-ups (6 months post-intervention)
|
Participants will be asked to complete self-report questionnaires about their personality traits, traumatic childhood experiences, perceived stress, current mood states and cigarette withdrawal symptoms
|
Multiple time points at baseline, during the intervention, at test sessions (24 hours, 2 weeks and 6 weeks post-intervention) and telephone follow-ups (6 months post-intervention)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Marco Leyton, PhD, McGill University
Publicações e links úteis
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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)
20 de fevereiro de 2018
Conclusão Primária (Real)
1 de maio de 2020
Conclusão do estudo (Antecipado)
31 de janeiro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
3 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de abril de 2021
Primeira postagem (Real)
14 de abril de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 421-0318
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
We will share deidentified individual participant data that underlie any results reported in the article.
This includes results reported in text, figures and appendices.
Prazo de Compartilhamento de IPD
From 9 to 36 months following article publication.
Critérios de acesso de compartilhamento IPD
Investigators whose proposed use of the data has already been approved by an ethics committee.
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
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