Investigation of Cigarette Cravings in Smokers

• ClinicalTrials.gov Identifier: NCT04843969
• Recruitment Status: Active, not recruiting
• First Posted: April 14, 2021
• Last Update Posted: April 14, 2021
• Sponsor: Marco Leyton
• Information provided by (Responsible Party): Marco Leyton, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking; Addiction Nicotine; Tobacco Use	Behavioral: Stress induction; Behavioral: Control stress exposure; Behavioral: Cue induction; Behavioral: Neutral cue exposure	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Investigating Stress-Potentiated Memory Updating as a Novel Intervention for Non-Treatment Seeking Smokers
• Actual Study Start Date: February 20, 2018
• Actual Primary Completion Date: May 1, 2020
• Estimated Study Completion Date: January 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Stress task and smoking cue; Exposure to a psychosocial stress task followed by smoking video cues	Behavioral: Stress induction; Exposure to a psychosocial stressor; Behavioral: Cue induction; Exposure to a smoking-related task
Experimental: Stress task and neutral cue; Exposure to a psychosocial stress task followed by neutral video cues	Behavioral: Stress induction; Exposure to a psychosocial stressor; Behavioral: Neutral cue exposure; Exposure to neutral cues
Active Comparator: Control task and smoking cue; Exposure to a control task followed by smoking video cues	Behavioral: Control stress exposure; Exposure to a control task (no stress); Behavioral: Cue induction; Exposure to a smoking-related task
Active Comparator: Control task and neutral cue; Exposure to a control task followed by neutral video cues	Behavioral: Control stress exposure; Exposure to a control task (no stress); Behavioral: Neutral cue exposure; Exposure to neutral cues

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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

Other Outcome Measures:

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Quebec

McGill University

Montreal, Quebec, Canada, H3A 1A1

Sponsors and Collaborators

Marco Leyton

Investigators

• Principal Investigator: Marco Leyton, PhD; McGill University

More Information

• Responsible Party: Marco Leyton, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
• ClinicalTrials.gov Identifier: NCT04843969
• Other Study ID Numbers: 421-0318
• First Posted: April 14, 2021
• Last Update Posted: April 14, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Time Frame: From 9 to 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has already been approved by an ethics committee.

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

Keywords provided by Marco Leyton, McGill University Health Centre/Research Institute of the McGill University Health Centre:

Memory updating; Reconsolidation

Additional relevant MeSH terms:

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior