Clinical trial NCT04843969: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cigarette Smoking
Addiction Nicotine
Tobacco Use
Keywords: Memory updating
Reconsolidation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: 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:
measure: Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
timeFrame: Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
measure: Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 3
timeFrame: Multiple times points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention.
measure: Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 2
timeFrame: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
measure: Change in smoking cue-induced heart rate responses from the pre-intervention baseline to test session 3
timeFrame: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
measure: Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 2
timeFrame: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
measure: Change in smoking cue-induced skin conductance responses from the pre-intervention baseline to test session 3
timeFrame: Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
measure: Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to during COVID-19
timeFrame: Multiple time points at baseline (before the pandemic), at the start of the pandemic, and during the pandemic
measure: Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to post-COVID-19
timeFrame: At baseline (before the pandemic) and through study completion, an average of 1 year
measure: Change in tobacco and other substance use patterns during the COVID-19 pandemic to post-COVID-19
timeFrame: Multiple time points during the pandemic and through study completion, an average of 1 year
Other outcomes:
measure: Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
timeFrame: Multiple time points during the intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention
measure: 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
timeFrame: 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)
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Marco Leyton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.