Investigation of Cigarette Cravings in Smokers

Tobacco Use Clinical Trial

Official title:

Investigating Stress-Potentiated Memory Updating as a Novel Intervention for Non-Treatment Seeking Smokers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04843969
• Other study ID #: 421-0318
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: January 31, 2022
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction Nicotine
• Behavior, Addictive
• Cigarette Smoking
• Tobacco Use

Intervention

Behavioral:
• Stress induction
Exposure to a psychosocial stressor
• Control stress exposure
Exposure to a control task (no stress)
• Cue induction
Exposure to a smoking-related task
• Neutral cue exposure
Exposure to neutral cues

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Marco Leyton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3	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
Other	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	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)
Primary	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	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	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	Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
Secondary	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	Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
Secondary	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	Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Secondary	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	Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Secondary	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	Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Secondary	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	Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
Secondary	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	Multiple time points at baseline (before the pandemic), at the start of the pandemic, and during the pandemic
Secondary	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	At baseline (before the pandemic) and through study completion, an average of 1 year
Secondary	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	Multiple time points during the pandemic and through study completion, an average of 1 year