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

NCT01507909 | Terminated

• 1 other identifier: EEG CUE study-H-31322
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Craving

Keywords

EEG; related visual; and verbal cues

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Local participants not interested in alcohol treatment.

You may qualify if:

• Male or female, aged 21 to 70.
• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Ofra Sarid-Segal, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the Clinical Studies Unit

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

US (1)