NCT04843969

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

April 3, 2021

Last Update Submit

April 11, 2021

Conditions

Keywords

Memory updatingReconsolidation

Outcome Measures

Primary Outcomes (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

    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 Outcomes (9)

  • Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2

    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

    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

    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

    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

    Multiple time points during the baseline, intervention and test sessions at 24 hours, 2 weeks and 6 weeks post-intervention

  • +4 more secondary outcomes

Other Outcomes (2)

  • Change in stress- and/or cue-induced mood 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

  • 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

    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)

Study Arms (4)

Stress task and smoking cue

EXPERIMENTAL

Exposure to a psychosocial stress task followed by smoking video cues

Behavioral: Stress inductionBehavioral: Cue induction

Stress task and neutral cue

EXPERIMENTAL

Exposure to a psychosocial stress task followed by neutral video cues

Behavioral: Stress inductionBehavioral: Neutral cue exposure

Control task and smoking cue

ACTIVE COMPARATOR

Exposure to a control task followed by smoking video cues

Behavioral: Control stress exposureBehavioral: Cue induction

Control task and neutral cue

ACTIVE COMPARATOR

Exposure to a control task followed by neutral video cues

Behavioral: Control stress exposureBehavioral: Neutral cue exposure

Interventions

Exposure to a psychosocial stressor

Stress task and neutral cueStress task and smoking cue

Exposure to a control task (no stress)

Control task and neutral cueControl task and smoking cue
Cue inductionBEHAVIORAL

Exposure to a smoking-related task

Control task and smoking cueStress task and smoking cue

Exposure to neutral cues

Control task and neutral cueStress task and neutral cue

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scoring 5 or higher on the Fagerström Test for Cigarette Dependence
  • Willingness to abstain from smoking for 4 hours prior to each laboratory visit

You may not qualify if:

  • Currently using cigarette cessation products
  • Endocrinological problems
  • Significant mental or physical health conditions
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cigarette SmokingTobacco Use DisorderTobacco Use

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Marco Leyton, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2021

First Posted

April 14, 2021

Study Start

February 20, 2018

Primary Completion

May 1, 2020

Study Completion

January 31, 2022

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

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.

Locations