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

This study has been terminated.
(Equipment Failure)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507909
First Posted: January 11, 2012
Last Update Posted: July 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ofra Sarid-Segal MD, Boston University
  Purpose
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.

Condition
Alcohol Craving

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative EEG Assessment of Cue-Induced Changes in Brain Activity in Alcohol Use Disorders

Resource links provided by NLM:


Further study details as provided by Ofra Sarid-Segal MD, Boston University:

Primary Outcome Measures:
  • 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.


Enrollment: 11
Study Start Date: January 2012
Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Local participants not interested in alcohol treatment.
Criteria

Inclusion Criteria:

  1. Male or female, aged 21 to 70.
  2. 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.
  3. The subject must currently not be in treatment for any alcohol use disorder
  4. Subject must be able to comprehend and perform study related information and tasks in English and have a willingness to complete study procedures.
  5. Subject must be able to provide written informed consent, at time of consent BAC has to be 0.00%.
  6. The subject must have the ability to read/speak English

Exclusion Criteria:

  1. Severe impairment of sight, smell, or hearing that would result in a significant alteration in the response to alcohol related cues.
  2. 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.
  3. 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.
  4. 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.
  5. The subject must not be pregnant. -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507909


Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Ofra Sarid-Segal, MD Boston University
  More Information

Responsible Party: Ofra Sarid-Segal MD, Medical Director of the Clinical Studies Unit, Boston University
ClinicalTrials.gov Identifier: NCT01507909     History of Changes
Other Study ID Numbers: EEG CUE study-H-31322
First Submitted: January 9, 2012
First Posted: January 11, 2012
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Ofra Sarid-Segal MD, Boston University:
EEG
related visual
and verbal cues