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Investigation of Cigarette Cravings in Smokers

11. april 2021 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Stress task and smoking cue
Exposure to a psychosocial stress task followed by smoking video cues
Adfærdsmæssigt: Stress induction
Exposure to a psychosocial stressor
Adfærdsmæssigt: Cue induction
Exposure to a smoking-related task
Eksperimentel: Stress task and neutral cue
Exposure to a psychosocial stress task followed by neutral video cues
Adfærdsmæssigt: Stress induction
Exposure to a psychosocial stressor
Adfærdsmæssigt: Neutral cue exposure
Exposure to neutral cues
Aktiv komparator: Control task and smoking cue
Exposure to a control task followed by smoking video cues
Adfærdsmæssigt: Cue induction
Exposure to a smoking-related task
Adfærdsmæssigt: Control stress exposure
Exposure to a control task (no stress)
Aktiv komparator: Control task and neutral cue
Exposure to a control task followed by neutral video cues
Adfærdsmæssigt: Neutral cue exposure
Exposure to neutral cues
Adfærdsmæssigt: Control stress exposure
Exposure to a control task (no stress)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Marco Leyton

Efterforskere

  • Ledende efterforsker: Marco Leyton, PhD, McGill University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. februar 2018

Primær færdiggørelse (Faktiske)

1. maj 2020

Studieafslutning (Forventet)

31. januar 2022

Datoer for studieregistrering

Først indsendt

3. april 2021

Først indsendt, der opfyldte QC-kriterier

11. april 2021

Først opslået (Faktiske)

14. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 421-0318

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

We will share deidentified individual participant data that underlie any results reported in the article. This includes results reported in text, figures and appendices.

IPD-delingstidsramme

From 9 to 36 months following article publication.

IPD-delingsadgangskriterier

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

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