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

NCT ID: NCT01507909

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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. -

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Ofra Sarid-Segal MD

Medical Director of the Clinical Studies Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ofra Sarid-Segal, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

EEG CUE study-H-31322

Identifier Type: -

Identifier Source: org_study_id