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临床试验/NCT04843969
NCT04843969Unknown不适用

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

Marco Leyton2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年2月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
76
试验地点
2
主要终点
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention

时间窗: 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

次要结局

  • 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)
  • Change in smoking cue-induced skin conductance 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 tobacco and other substance use patterns from the pre-COVID-19 baseline to during COVID-19(Multiple time points at baseline (before the pandemic), at the start of the pandemic, and during the pandemic)
  • Change in tobacco and other substance use patterns from the pre-COVID-19 baseline to post-COVID-19(At baseline (before the pandemic) and through study completion, an average of 1 year)
  • Change in tobacco and other substance use patterns during the COVID-19 pandemic to post-COVID-19(Multiple time points during the pandemic and through study completion, an average of 1 year)

研究者

发起方
Marco Leyton
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marco Leyton

Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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