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Investigation of Cigarette Cravings in Smokers

11 april 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

76

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Stress task and smoking cue
Exposure to a psychosocial stress task followed by smoking video cues
Gedragsmatig: Stress induction
Exposure to a psychosocial stressor
Gedragsmatig: Cue induction
Exposure to a smoking-related task
Experimenteel: Stress task and neutral cue
Exposure to a psychosocial stress task followed by neutral video cues
Gedragsmatig: Stress induction
Exposure to a psychosocial stressor
Gedragsmatig: Neutral cue exposure
Exposure to neutral cues
Actieve vergelijker: Control task and smoking cue
Exposure to a control task followed by smoking video cues
Gedragsmatig: Cue induction
Exposure to a smoking-related task
Gedragsmatig: Control stress exposure
Exposure to a control task (no stress)
Actieve vergelijker: Control task and neutral cue
Exposure to a control task followed by neutral video cues
Gedragsmatig: Neutral cue exposure
Exposure to neutral cues
Gedragsmatig: Control stress exposure
Exposure to a control task (no stress)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Marco Leyton

Onderzoekers

  • Hoofdonderzoeker: Marco Leyton, PhD, McGill University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 februari 2018

Primaire voltooiing (Werkelijk)

1 mei 2020

Studie voltooiing (Verwacht)

31 januari 2022

Studieregistratiedata

Eerst ingediend

3 april 2021

Eerst ingediend dat voldeed aan de QC-criteria

11 april 2021

Eerst geplaatst (Werkelijk)

14 april 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 april 2021

Laatste update ingediend die voldeed aan QC-criteria

11 april 2021

Laatst geverifieerd

1 april 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 421-0318

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

From 9 to 36 months following article publication.

IPD-toegangscriteria voor delen

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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