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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Boston University
Sponsor:
Information provided by (Responsible Party):
Ofra Sarid-Segal MD, Boston University
ClinicalTrials.gov Identifier:
NCT01507909
First received: January 9, 2012
Last updated: July 25, 2012
Last verified: July 2012
  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 Boston University:

Primary Outcome Measures:
  • FFT power of five frequency bands [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507909

Contacts
Contact: Ofra Sarid-Segal, MD 617-414-1990 ofra.segal@bmc.org

Locations
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Ofra Sarid-Segal, MD    617-414-1990    ofra.segal@bmc.org   
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Ofra Sarid-Segal, MD Boston University
  More Information

No publications provided

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
Study First Received: January 9, 2012
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
EEG
related visual
and verbal cues

ClinicalTrials.gov processed this record on October 23, 2014