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Investigation of Cigarette Cravings in Smokers

Primary Purpose

Cigarette Smoking, Addiction Nicotine, Tobacco Use

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stress induction
Control stress exposure
Cue induction
Neutral cue exposure
Sponsored by
Marco Leyton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cigarette Smoking focused on measuring Memory updating, Reconsolidation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Stress task and smoking cue

Stress task and neutral cue

Control task and smoking cue

Control task and neutral cue

Arm Description

Exposure to a psychosocial stress task followed by smoking video cues

Exposure to a psychosocial stress task followed by neutral video cues

Exposure to a control task followed by smoking video cues

Exposure to a control task followed by neutral video cues

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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

Full Information

First Posted
April 3, 2021
Last Updated
April 11, 2021
Sponsor
Marco Leyton
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1. Study Identification

Unique Protocol Identification Number
NCT04843969
Brief Title
Investigation of Cigarette Cravings in Smokers
Official Title
Investigating Stress-Potentiated Memory Updating as a Novel Intervention for Non-Treatment Seeking Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Leyton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Addiction Nicotine, Tobacco Use
Keywords
Memory updating, Reconsolidation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress task and smoking cue
Arm Type
Experimental
Arm Description
Exposure to a psychosocial stress task followed by smoking video cues
Arm Title
Stress task and neutral cue
Arm Type
Experimental
Arm Description
Exposure to a psychosocial stress task followed by neutral video cues
Arm Title
Control task and smoking cue
Arm Type
Active Comparator
Arm Description
Exposure to a control task followed by smoking video cues
Arm Title
Control task and neutral cue
Arm Type
Active Comparator
Arm Description
Exposure to a control task followed by neutral video cues
Intervention Type
Behavioral
Intervention Name(s)
Stress induction
Intervention Description
Exposure to a psychosocial stressor
Intervention Type
Behavioral
Intervention Name(s)
Control stress exposure
Intervention Description
Exposure to a control task (no stress)
Intervention Type
Behavioral
Intervention Name(s)
Cue induction
Intervention Description
Exposure to a smoking-related task
Intervention Type
Behavioral
Intervention Name(s)
Neutral cue exposure
Intervention Description
Exposure to neutral cues
Primary Outcome Measure Information:
Title
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
Description
A journal is given to participants to record their cigarette use behaviour every day for a month and a half
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).
Secondary Outcome Measure Information:
Title
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
Description
Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions
Time Frame
Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
Title
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 3
Description
Participants will be asked to complete craving and urge to smoke questionnaires at several time points throughout the study sessions
Time Frame
Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
Title
Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 2
Description
Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions
Time Frame
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Title
Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 3
Description
Participants' heart rate will be measured through the use of a polar belt at several time points during the study sessions
Time Frame
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Title
Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 2
Description
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
Time Frame
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Title
Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 3
Description
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
Time Frame
Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Title
Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to during COVID-19
Description
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
Time Frame
Multiple time points at baseline (before the pandemic), at the start of the pandemic, and during the pandemic
Title
Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to post-COVID-19
Description
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
Time Frame
At baseline (before the pandemic) and through study completion, an average of 1 year
Title
Change in tobacco and other substance use patterns during the COVID-19 pandemic to post-COVID-19
Description
Participants will be asked to report the quantity of cigarettes and/or other substances they have consumed recently
Time Frame
Multiple time points during the pandemic and through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
Description
Participants will be asked to complete a mood questionnaire at several time points 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
Title
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
Description
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
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Leyton, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 Sharing Time Frame
From 9 to 36 months following article publication.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has already been approved by an ethics committee.
Citations:
PubMed Identifier
36175551
Citation
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.
Results Reference
derived

Learn more about this trial

Investigation of Cigarette Cravings in Smokers

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