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Clinical Trials/NCT01507909
NCT01507909
Terminated
Not Applicable

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

Boston University1 site in 1 country11 target enrollmentStarted: January 2012Last updated:
ConditionsAlcohol Craving

Overview

Phase
Not Applicable
Status
Terminated
Enrollment
11
Locations
1
Primary Endpoint
FFT power of five frequency bands

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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. -

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ofra Sarid-Segal MD

Medical Director of the Clinical Studies Unit

Boston University

Study Sites (1)

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