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临床试验/NCT04310735
NCT04310735已完成不适用

Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

Penn State University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Brain Activation During Smoking-related and Neutral Cues

研究概览

简要总结

The study will use functional magnetic resonance imaging and facial coding methods to study individuals who smoke cigarettes. Smoking expectancy (the extent to which one perceives an opportunity to smoke a cigarette) will be manipulated using instructions, and the investigators will examine the effects of this manipulation on two primary endpoints under conditions designed to induce an urge to smoke: (1) brain responses measured using fMRI and (2) subjective affective responses measured using facial coding. Secondary endpoints include self-report measures of the desire to smoke and current affect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be between the ages of 21 and
  • Participants must be right handed.
  • Participants must be fluent English speakers.
  • Participants must report smoking at least 6 cigarettes per day continuously for at least the 12 preceding months.
  • Participants must have a baseline expired air carbon monoxide (CO) exceeding a cutoff based upon prior research in order to verify smoking status.

排除标准

  • Individuals will be excluded if they report that they are actively trying to quit smoking.
  • Individuals will be excluded if they report that they have had significant cardiovascular disease (such as heart disease, heart attack, stroke, or angina) or respiratory disease (such as asthma, chronic bronchitis, or COPD) during the past year.
  • Individuals will be excluded if they report that they have used any of the following illicit substances more than 10 times in the previous 30 days: marijuana, cocaine, opiates such as heroin, methadone, benzodiazepines (such as Valium, Xanax), barbiturates, amphetamines, methamphetamines, PCP, LSD or any other hallucinogen.
  • Individuals will be excluded if they report that they are currently taking prescription medications that previously have been found to affect blood flow responses in the brain.
  • Individuals will be excluded if they have any known risk from exposure to high-field strength magnetic fields (e.g., pace makers), any irremovable metallic foreign objects in their body (e.g., braces), or a questionable history of metallic fragments that are likely to create artifact on the MRI scans.
  • Individuals will be excluded if they meet criteria for current dependence on a substance other than nicotine based upon a brief structured interview.
  • Individuals will be excluded if they report that they are not willing to refrain from using alcohol and recreational drugs for 24 hours and nicotine for 12 hours before the experimental lab visit.
  • Individuals will be excluded if they currently use nicotine products other than cigarettes (e.g., chewing tobacco, snuff, e-cigarettes, or smoking cessation products).
  • Individuals will be excluded if they are claustrophobic or are prone to becoming very uncomfortable in confined spaces.
  • Individuals will be excluded if they report that they exclusively or primarily smoke "roll-your-own" cigarettes.

研究组 & 干预措施

Experimental: Expect-Yes

Experimental

Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session.

干预措施: Verbal smoking expectancy manipulation (Behavioral)

Experimental: Expect-No

Experimental

Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session.

干预措施: Verbal smoking expectancy manipulation (Behavioral)

结局指标

主要结局

Brain Activation During Smoking-related and Neutral Cues

时间窗: Approximately Day 7 (Visit 2)

Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging (fMRI) was analyzed as participants were presented with smoking-related and neutral cues. Following preprocessing with fMRIPrep (version 20.2.7), the FMRI Expert Analysis Tool (FEAT) from FMRIB's Software Library (FSL; version 6.0.7.4) was used to characterize brain activation differences in response to smoking-related versus neutral cues. Contrast of parameter estimate (COPE) values were calculated for each participant, and these COPE values were then extracted for two a priori regions of interest (ROIs) to compare activation patterns between the groups. Larger COPE values indicate greater differences in brain activation between smoking-related and neutral cues,

Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues

时间窗: Approximately Day 7 (Visit 2)

Subjective affective responses were measured by using FaceReader software (version 9.1.7) to code the valence (positive or negative) of facial movements associated with emotional expression during the presentation of smoking-related and neutral cues. Possible values for valence range from -1 to 1, with higher values indicating greater positive affect,

次要结局

  • Self-reported Urge to Smoke During Smoking-related and Neutral Cues(Approximately Day 7 (Visit 2))
  • Self-reported Affect During Smoking-related and Neutral Cues(Approximately Day 7 (Visit 2))
  • Nicotine Dependence(Day 1 (Visit 1))
  • Brain Activation During Positive and Negative Emotion Cues(Approximately Day 7 (Visit 2))
  • Self-reported Affect During Positive and Negative Emotion Cues(Approximately Day 7 (Visit 2))
  • Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues(Approximately Day 7 (Visit 2))
  • Self-reported Urge to Smoke During Positive and Negative Emotion Cues(Approximately Day 7 (Visit 2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Wilson

Associate Professor

Penn State University

研究点 (2)

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