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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
77
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
South Carolina
-
Charleston、South Carolina、美国、29425
- Medical University of South Carolina
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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.
|
A relatively brief exposure to cues prior to conducting more protracted cue exposure.
This is referred to as retrieval-extinction training.
其他名称：
|
|
其他：Non-Retrieval Extinction: Neutral Cues
This is the group that will not receive retrieval-extinction training and will be exposed to neutral cues.
|
Neutral cue exposure.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean of the Difference in Nicotine Craving between Visits 1 and 2
大体时间：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.
|
A craving questionnaire and mood form is given to participants to complete at several time points throughout the visit to access nicotine craving.
|
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.
|
|
Change in Nicotine Use at 2-Week Follow-Up
大体时间：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.
|
A diary is given to participants to record their smoking behaviors everyday for two weeks.
|
|
Change in Nicotine Use at 4-Week Follow-up
大体时间：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.
|
A diary is given to participants to record their smoking behaviors everyday for two weeks.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年12月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2014年3月28日
首先提交符合 QC 标准的
2014年5月30日
首次发布 (估计)
2014年6月3日
研究记录更新
最后更新发布 (估计)
2015年10月2日
上次提交的符合 QC 标准的更新
2015年10月1日
最后验证
2015年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.