Investigation of Cigarette Cravings in Smokers
2021年4月11日 更新者：Marco Leyton
Investigating Stress-Potentiated Memory Updating as a Novel Intervention for Non-Treatment Seeking Smokers
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.
調査の概要
状態
積極的、募集していない
詳細な説明
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.
研究の種類
介入
入学 (実際)
76
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Quebec
-
Montreal、Quebec、カナダ、H3A 1A1
- McGill University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Stress task and smoking cue
Exposure to a psychosocial stress task followed by smoking video cues
|
Exposure to a psychosocial stressor
Exposure to a smoking-related task
|
|
実験的：Stress task and neutral cue
Exposure to a psychosocial stress task followed by neutral video cues
|
Exposure to a psychosocial stressor
Exposure to neutral cues
|
|
アクティブコンパレータ：Control task and smoking cue
Exposure to a control task followed by smoking video cues
|
Exposure to a smoking-related task
Exposure to a control task (no stress)
|
|
アクティブコンパレータ：Control task and neutral cue
Exposure to a control task followed by neutral video cues
|
Exposure to neutral cues
Exposure to a control task (no stress)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in cigarettes smoked per day from the pre-intervention baseline to test sessions 2 and 3 given two and six weeks post-intervention
時間枠：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
|
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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in smoking cue-induced cigarette cravings from the pre-intervention baseline to test session 2
時間枠：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
|
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
時間枠：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
|
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
時間枠：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
|
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
時間枠：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
|
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
時間枠：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
|
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
時間枠：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
|
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
時間枠：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
|
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
時間枠：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
|
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
時間枠：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
|
Multiple time points during the pandemic and through study completion, an average of 1 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in stress- and/or cue-induced mood during the intervention and at test sessions 1, 2 and 3
時間枠：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
|
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
時間枠：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
|
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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Marco Leyton, PhD、McGill University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年2月20日
一次修了 (実際)
2020年5月1日
研究の完了 (予想される)
2022年1月31日
試験登録日
最初に提出
2021年4月3日
QC基準を満たした最初の提出物
2021年4月11日
最初の投稿 (実際)
2021年4月14日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月14日
QC基準を満たした最後の更新が送信されました
2021年4月11日
最終確認日
2021年4月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
We will share deidentified individual participant data that underlie any results reported in the article.
This includes results reported in text, figures and appendices.
IPD 共有時間枠
From 9 to 36 months following article publication.
IPD 共有アクセス基準
Investigators whose proposed use of the data has already been approved by an ethics committee.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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