Quantitative EEG Assessment of Cue-Induced Changes in Bra... | NCT01507909

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

NCT01507909

Sponsor

Boston University

Status

Terminated

Last Update Posted

Jul 26, 2016Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Alcohol Craving

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Equipment Failure

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 10, 2012

First Posted Date

Jan 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Severe impairment of sight, smell, or hearing that would result in a significant alteration in the response to alcohol related cues.
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.
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.
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.
The subject must not be pregnant. -

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Local participants not interested in alcohol treatment.

Sampling Method

Non-Probability Sample