NCT00300638

Brief Summary

The purpose of this study is to determine whether long-term chronic alcoholism is associated with changes in emotional functioning and brain structure and function.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
599

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

18.6 years

First QC Date

March 7, 2006

Last Update Submit

July 15, 2021

Conditions

Keywords

AlcoholismEmotionCognitionBrain scans

Outcome Measures

Primary Outcomes (1)

  • Alcoholism's effects on thinking, behavior and brain functioning

    several visits over approximately one month

Study Arms (1)

1- MRI and interviews

In our research, we are trying to understand where in the brain these emotional behaviors take place, and whether or not the brain functions differently for alcoholic and nonalcoholic individuals. We present emotional words and pictures on a computer screen, and using Magnetic Resonance Imaging (MRI) scans, we observe how the brain works when people purposefully respond to the words and pictures. Interviews, cognitive tests, and emotional measurements will also be done. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.

Procedure: Magnetic Resonance Imaging (MRI)Behavioral: Interviews, cognitive tests, and emotional measurements

Interventions

We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.

1- MRI and interviews

We present emotional words and pictures on a computer screen, and using MRI scans, we observe how the brain works when people purposefully respond to the words and pictures. Additionally, we are comparing brain structure and activation patterns in men and women, because there may be gender differences in responses to emotional stimuli.

1- MRI and interviews

Eligibility Criteria

Age25 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Alcoholics and demographically equivalent healthy controls who have participated in one or more of our prior studies are contacted by telephone to determine whether or not they would like to participate again. Potential participants who have not previously been enlisted in any of our studies are recruited through fliers placed in the Boston Veterans Affairs Healthcare System, BU School of Medicine, and after-care programs in the Boston area, and through ads in local newspapers and web sites. For "new" participants, subject selection procedures include an initial prescreening telephone interview to determine identifying information such as age, level of education, health history, and history of alcohol and drug use and if eligible are invited to the laboratory for further screening and neuropsychological evaluations.

You may qualify if:

  • Male and female right-handed people 25 years of age or older.
  • Participants either will have a past Diagnostic and Statistical Manual version IV (DSM-IV) diagnosis of alcohol dependence, or no such history at all.
  • Participants will have signed an informed consent.

You may not qualify if:

  • Pregnant women.
  • Shrapnel or other metal in body (dental fillings OK)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Hospital and Massachusetts General Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • Oscar-Berman M, Marinkovic K. Alcoholism and the brain: an overview. Alcohol Res Health. 2003;27(2):125-33.

    PMID: 15303622BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Magnetic Resonance SpectroscopyInterviews as TopicNeuropsychological Tests

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Marlene O. Berman, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

August 1, 2001

Primary Completion

February 21, 2020

Study Completion

February 21, 2020

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations