Cigarette SmokingNCT04843969
Investigation of Cigarette Cravings in Smokers
A study testing Stress induction, Cue induction and Neutral cue exposure in people with Cigarette Smoking and Addiction Nicotine, run by Marco Leyton at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cigarette Smoking, Addiction Nicotine, Tobacco Use
- What is being tested?
- Stress induction, Cue induction and Neutral cue exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scoring 5 or higher on the Fagerström Test for Cigarette Dependence
- Willingness to abstain from smoking for 4 hours prior to each laboratory visit
Who cannot join
- Currently using cigarette cessation products
- Endocrinological problems
- Significant mental or physical health conditions
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cigarette Smoking, Addiction Nicotine, Tobacco Use
- Being tested
- Stress induction, Control stress exposure, Cue induction, Neutral cue exposure
- Keywords
- Memory updating, Reconsolidation
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress inductionBehavioural
Exposure to a psychosocial stressor
Control stress exposureBehavioural
Exposure to a control task (no stress)
Cue inductionBehavioural
Exposure to a smoking-related task
Neutral cue exposureBehavioural
Exposure to neutral cues
| Study group | Role | What they receive |
|---|---|---|
| Stress task and smoking cue | Experimental | Exposure to a psychosocial stress task followed by smoking video cues Receives: Behavioral: Stress induction; Behavioral: Cue induction |
| Stress task and neutral cue | Experimental | Exposure to a psychosocial stress task followed by neutral video cues Receives: Behavioral: Stress induction; Behavioral: Neutral cue exposure |
| Control task and smoking cue | Active comparator | Exposure to a control task followed by smoking video cues Receives: Behavioral: Control stress exposure; Behavioral: Cue induction |
| Control task and neutral cue | Active comparator | Exposure to a control task followed by neutral video cues Receives: Behavioral: Control stress exposure; Behavioral: Neutral cue exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
A journal is given to participants to record their cigarette use behaviour every day for a month and a half
Measured: 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 outcomes (9)
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions
Measured: 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
Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions
Measured: 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
Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions
Measured: 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
Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions
Measured: 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
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
Measured: 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
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
Measured: 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
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
Measured: 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
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
Measured: 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
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
Measured: Multiple time points during the pandemic and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start20 Feb 2018
- Primary completion1 May 2020
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Leyton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Leyton, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Marco Leyton, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843969
- Sponsor's protocol ID
- 421-0318
- Status last verified
- Apr 2021
- First submitted
- 3 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share deidentified individual participant data that underlie any results reported in the article. This includes results reported in text, figures and appendices.
Publications
Barnabe A, Gamache K, de Camargo JVP, Allen-Flanagan E, Rioux M, Pruessner J, Leyton M, Nader K. A novel stress-based intervention reduces cigarette use in non-treatment seeking smokers. Neuropsychopharmacology. 2023 Jan;48(2):308-316. doi: 10.1038/s41386-022-01455-6. Epub 2022 Sep 29.
PubMed 36175551
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Stress-Potentiated Memory Updating as a Novel Intervention for Non-Treatment Seeking Smokers
- ClinicalTrials.gov ID
- NCT04843969
- Acronym / sponsor ID
- 421-0318
- Conditions
- Cigarette Smoking, Addiction Nicotine, Tobacco Use
- Keywords
- Memory updating, Reconsolidation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Marco LeytonUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stress task and smoking cue | Experimental | Behavioral: Stress induction, Behavioral: Cue inductionExposure to a psychosocial stress task followed by smoking video cues |
| Stress task and neutral cue | Experimental | Behavioral: Stress induction, Behavioral: Neutral cue exposureExposure to a psychosocial stress task followed by neutral video cues |
| Control task and smoking cue | Active comparator | Behavioral: Control stress exposure, Behavioral: Cue inductionExposure to a control task followed by smoking video cues |
| Control task and neutral cue | Active comparator | Behavioral: Control stress exposure, Behavioral: Neutral cue exposureExposure to a control task followed by neutral video cues |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scoring 5 or higher on the Fagerström Test for Cigarette Dependence
- Willingness to abstain from smoking for 4 hours prior to each laboratory visit
Key exclusion criteria (4 listed)
- Currently using cigarette cessation products
- Endocrinological problems
- Significant mental or physical health conditions
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress inductionExposure to a psychosocial stressor | Behavioural | Stress task and neutral cue, Stress task and smoking cue |
| Control stress exposureExposure to a control task (no stress) | Behavioural | Control task and neutral cue, Control task and smoking cue |
| Cue inductionExposure to a smoking-related task | Behavioural | Control task and smoking cue, Stress task and smoking cue |
| Neutral cue exposureExposure to neutral cues | Behavioural | Control task and neutral cue, Stress task and neutral cue |
Primary outcome
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
9 secondary outcomes
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.
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.
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 36175551Barnabe A, Gamache K, de Camargo JVP, Allen-Flanagan E, Rioux M, Pruessner J, Leyton M, Nader K. A novel stress-based intervention reduces cigarette use in non-treatment seeking smokers. Neuropsychopharmacology. 2023 Jan;48(2):308-316. doi: 10.1038/s41386-022-01455-6. Epub 2022 Sep 29.
- Individual participant dataSharing planned: Yes. We will share deidentified individual participant data that underlie any results reported in the article. This includes results reported in text, figures and appendices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Leyton, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress induction, Cue induction and Neutral cue exposure in people with Cigarette Smoking and Addiction Nicotine, run by Marco Leyton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.