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Investigation of Cigarette Cravings in Smokers

11 aprile 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

76

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Stress task and smoking cue
Exposure to a psychosocial stress task followed by smoking video cues
Comportamentale: Stress induction
Exposure to a psychosocial stressor
Comportamentale: Cue induction
Exposure to a smoking-related task
Sperimentale: Stress task and neutral cue
Exposure to a psychosocial stress task followed by neutral video cues
Comportamentale: Stress induction
Exposure to a psychosocial stressor
Comportamentale: Neutral cue exposure
Exposure to neutral cues
Comparatore attivo: Control task and smoking cue
Exposure to a control task followed by smoking video cues
Comportamentale: Cue induction
Exposure to a smoking-related task
Comportamentale: Control stress exposure
Exposure to a control task (no stress)
Comparatore attivo: Control task and neutral cue
Exposure to a control task followed by neutral video cues
Comportamentale: Neutral cue exposure
Exposure to neutral cues
Comportamentale: Control stress exposure
Exposure to a control task (no stress)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to post-COVID-19
Lasso di tempo: At baseline (before 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
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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
Lasso di tempo: 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
Multiple time points during the intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Marco Leyton

Investigatori

  • Investigatore principale: Marco Leyton, PhD, McGill University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 febbraio 2018

Completamento primario (Effettivo)

1 maggio 2020

Completamento dello studio (Anticipato)

31 gennaio 2022

Date di iscrizione allo studio

Primo inviato

3 aprile 2021

Primo inviato che soddisfa i criteri di controllo qualità

11 aprile 2021

Primo Inserito (Effettivo)

14 aprile 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 aprile 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 aprile 2021

Ultimo verificato

1 aprile 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 421-0318

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

From 9 to 36 months following article publication.

Criteri di accesso alla condivisione IPD

Investigators whose proposed use of the data has already been approved by an ethics committee.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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