- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04843969
Investigation of Cigarette Cravings in Smokers
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- McGill University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Exposure to a psychosocial stressor
Exposure to neutral cues
|
Active Comparator: Control task and smoking cue
Exposure to a control task followed by smoking video cues
|
Exposure to a smoking-related task
Exposure to a control task (no stress)
|
Active Comparator: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
Time Frame: 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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Leyton, PhD, McGill University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 421-0318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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