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

Alcohol Craving Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01507909
• Other study ID #: EEG CUE study-H-31322
• Status: Terminated
• Phase: N/A
• First received: January 9, 2012
• Last updated: July 25, 2016
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: July 2016
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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. -

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcohol Craving

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No