Extinction Updating in Reconsolidation
2015年10月1日 更新者：Medical University of South Carolina
Reducing Smoking Cue Reactivity and Behavior Via Retrieval-Extinction Mechanism
Smoking occurs in approximately 21% of the US population, is responsible for an annual mortality rate of approximately 438,000 citizens, and has an associated healthcare economic burden of $167 billion.
Although pharmacotherapies have improved cessation outcome, the vast majority of individuals making quit attempts relapse within 5-10 days of cessation.
The hypotheses to be examined in this study may have potentially important implications for smoking cessation treatment and will, therefore, target the single greatest addiction-related cause of morbidity and mortality.This study will investigate a novel behavioral strategy for altering important memory processes that underlie human smoking-related nicotine addiction.
This strategy used in this study employs established cue exposure procedures to putatively update smoking-related memory with information that will suppress responding to smoking cues.
The goal here is to alter existing nicotine-related memory directly rather than rely exclusively on the establishment of an inhibitory extinction process, via traditional cue exposure therapy, which is known to be vulnerable to spontaneous recovery, renewal and reinstatement.
Positive findings would represent a significant advance in exposure-based therapy for addiction and could lead to a treatment that uniquely targets the problem of cue-elicited craving and reactivity, thereby addressing a major obstacle to successful smoking cessation.
調査の概要
詳細な説明
We propose to examine the effects of two sessions of retrieval-extinction (R-E) training in smokers who are making a quit attempt.
Retrieval will be initiated by a brief (5-min.)
video with smoking-related content and the extinction will consist of protracted (1 hr.) exposure to smoking cues.
A control group receiving the same treatment except that the retrieval video will have nonsmoking/neutral content will serve to demonstrate that retrieval is a key feature of R-E training.
Effects of training on smoking craving and cue reactivity will be assessed 1-day, 2-weeks and 4-weeks post-training, whereas training effects on indices of smoking behavior/cessation will be preliminarily assessed 2-weeks and 4-weeks post-training.
It is expected that the R-E training will result in significant and enduring reductions in craving and reactivity to both novel and familiar smoking cues and have a favorable impact on smoking.
Positive findings from this study could lead to a safe and effective behavioral intervention that will help smokers overcome the threat to cessation posed by cue-elicited craving and reactivity, and thereby reduce the burden levied against society by this most costly addiction.
Additionally, this intervention could be modified to treat addiction to other substances.
研究の種類
介入
入学 (実際)
77
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
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
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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
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must meet DSM-IV criteria for current nicotine dependence and be a daily cigarette smoker of 10+ cigarettes/day for a minimum duration of three years.
- Participants must live within a 50-mile radius of the research facility and have reliable transportation.
- Participants must be willing to make a quit attempt beginning the night before the three consecutive daily laboratory sessions (i.e., two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session).
- Participants must be willing to (a) be overnight smoking abstinent (CO verified) prior to the baseline smoking cue reactivity assessment, and (b) make a cessation attempt and be smoking abstinent (CO verified) over the three day period that corresponds to the two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session.
- Participants must be willing to submit to a breathalyzer (alcohol) assessment and urine drug screen (for benzodiazepines, methamphetamine, cocaine, marijuana and opiates) and produce a negative test result on (a) the day of the baseline smoking cue reactivity assessment, and (b) each of the three consecutive days that correspond to the two retrieval-extinction training sessions and the test session performed 24-hours after the second retrieval-extinction training session.
- Participants must consent to random assignment to the R-E vs. NR-E conditions.
- Participants must not use smokeless tobacco.
- Participants must be willing to forego any other medication or behavioral treatment for smoking cessation during their enrollment in this study (with the exception of a referral, upon request, to the SC Quitline). Treatment referral will be provided at the end of the study.
Exclusion Criteria:
- Participants with current/active (untreated) psychotic disorder, current major depressive disorder (severe), bipolar affective disorder or a severe anxiety disorder as these conditions would likely interfere with their ability to fulfill the requirements for successful participation (e.g., provide accurate interview data, complete study assessments, attend scheduled laboratory visits, etc.).
- Participants meeting DSM-IV criteria for substance dependence (other than nicotine) within the past 60 days.
- Participants who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (benzodiazepines, methamphetamine, cocaine, marijuana and opiates) in order to comply with Inclusion Criterion f above.
- Participants currently taking ß-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate, skin conductance or blood pressure responses.
- Current use of any pharmacotherapy or psychotherapy for smoking cessation.
- Pregnant women (because pregnancy can influence responding during study procedures).
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 |
|---|---|
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他の：Retrieval-Extinction: Smoking Cues
A relatively brief exposure to cues prior to conducting more protracted cue exposure.
This is referred to as retrieval-extinction training.
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A relatively brief exposure to cues prior to conducting more protracted cue exposure.
This is referred to as retrieval-extinction training.
他の名前：
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他の：Non-Retrieval Extinction: Neutral Cues
This is the group that will not receive retrieval-extinction training and will be exposed to neutral cues.
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Neutral cue exposure.
他の名前：
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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 |
|---|---|---|
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Mean of the Difference in Nicotine Craving between Visits 1 and 2
時間枠：Multiple times points during Visits 1, 2 and 3 (the two retreival sessions and the first test session) as well as the 2-week and 4-week follow-up laboratory test sessions.
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A craving questionnaire and mood form is given to participants to complete at several time points throughout the visit to access nicotine craving.
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Multiple times points during Visits 1, 2 and 3 (the two retreival sessions and the first test session) as well as the 2-week and 4-week follow-up laboratory test sessions.
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Change in Nicotine Use at 2-Week Follow-Up
時間枠：A diary is given to participants to record their smoking behaviors everyday for two weeks.
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At the end of the first (24-hr.)
and second (2-wk) test session, participants will receive a smoking diary in which to record the occurrence of (a) daily smoking behavior, and (b) daily craving rating over the ensuing 2-week follow-up period.
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A diary is given to participants to record their smoking behaviors everyday for two weeks.
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Change in Nicotine Use at 4-Week Follow-up
時間枠：A diary is given to participants to record their smoking behaviors everyday for two weeks.
|
At the end of the first (24-hr.)
and second (2-wk) test session, participants will receive a smoking diary in which to record the occurrence of (a) daily smoking behavior, and (b) daily craving rating over the ensuing 2-week follow-up period.
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A diary is given to participants to record their smoking behaviors everyday for two weeks.
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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。
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。
一般刊行物
- Germeroth LJ, Baker NL, Saladin ME. Intolerance for smoking abstinence among nicotine-deprived, treatment-seeking smokers. Addict Behav. 2018 Sep;84:13-19. doi: 10.1016/j.addbeh.2018.03.019. Epub 2018 Mar 20.
- Germeroth LJ, Carpenter MJ, Baker NL, Froeliger B, LaRowe SD, Saladin ME. Effect of a Brief Memory Updating Intervention on Smoking Behavior: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Mar 1;74(3):214-223. doi: 10.1001/jamapsychiatry.2016.3148.
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
2013年12月1日
一次修了 (実際)
2015年9月1日
研究の完了 (実際)
2015年9月1日
試験登録日
最初に提出
2014年3月28日
QC基準を満たした最初の提出物
2014年5月30日
最初の投稿 (見積もり)
2014年6月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月2日
QC基準を満たした最後の更新が送信されました
2015年10月1日
最終確認日
2015年4月1日
詳しくは
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。