Clinical trial NCT01507909: Quantitative EEG Assessment of Cue-Induced Changes in Brain Activity in Alcohol Use Disorders
Official title: Quantitative EEG Assessment of Cue-Induced Changes in Brain Activity in Alcohol Use Disorders
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alcohol Craving
Keywords: EEG
related visual
and verbal cues
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local participants not interested in alcohol treatment.

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.


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. -

Primary outcomes:
measure: FFT power of five frequency bands
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Ofra Sarid-Segal, MD
role: PRINCIPAL_INVESTIGATOR
References: