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临床试验/NCT01507909
NCT01507909终止不适用

Quantitative EEG Assessment of Cue-Induced Changes in Brain Activity in Alcohol Use Disorders

Boston University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
1
主要终点
FFT power of five frequency bands

研究概览

简要总结

Exposure to alcohol related cues, such as the sight of alcoholic drinks, may induce craving for alcohol in drinkers. In this study, the effects of exposure to (1) the pictures of alcoholic drinks and (2) the imagining of a scene related to drinking on activity in the frontal region of the brain in heavy social drinkers will be determined. This study is being conducted to develop the methods needed to allow for the detection of cue-induced changes in drinkers using the EEG. The objective of this pilot study is to establish procedures for detecting alcohol-related cue-elicited changes in EEG activity in heavy drinkers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, aged 21 to
  • History of heavy drinking: Defined as at least 8 occasions in the past month that individual had at least 5 drinks (males) or 4 drinks (females) in one sitting.
  • The subject must currently not be in treatment for any alcohol use disorder
  • Subject must be able to comprehend and perform study related information and tasks in English and have a willingness to complete study procedures.
  • Subject must be able to provide written informed consent, at time of consent BAC has to be 0.00%.
  • The subject must have the ability to read/speak English

排除标准

  • Severe impairment of sight, smell, or hearing that would result in a significant alteration in the response to alcohol related cues.
  • Currently on a medication used to treat alcoholism or is known to alter EEG activity or responsiveness to cue presentation including acamprosate, anticonvulsants, anticholinergics, antipsychotics, benzodiazepine receptor agonists, beta adrenergic receptor antagonists, and naltrexone.
  • History of any neurological or psychiatric disorder that would result in abnormal EEG activity such as severe brain trauma, seizure disorders, stroke or that would severly alter response to the cue presentation such as schizophrenia or any other psychotic or severe mood disorder.
  • CIWA-AR score of 8 or higher or any history indicating that the subject is at risk for experiencing severe alcohol withdrawal symptoms if her or his drinking is discontinued for any period of time.
  • The subject must not be pregnant. -

结局指标

主要结局

FFT power of five frequency bands

This study will look at FFT power of five frequency bands. Relative power will be determined by finding absolute power for the range of frequencies (0,1 to 100Hz). Relative power will then be found for each electrode. The Investigator's will examine change over time for relative power for each electrode in the different cue condition and compare change of power using repeated measures analysis with time and condition as within subject factors. Craving values obtained under the different cue conditions will be analyzed using condition as the within-subject factor.

次要结局

未报告次要终点

研究者

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

Ofra Sarid-Segal MD

Medical Director of the Clinical Studies Unit

Boston University

研究点 (1)

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