Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/6/2019 |
| Start Date: | April 8, 2014 |
| End Date: | December 31, 2020 |
| Contact: | Reza Momenan, Ph.D. |
| Email: | rezam@mail.nih.gov |
| Phone: | (301) 451-6972 |
Background:
- People with alcoholism have differences in their brains compared with healthy people.
People who are dependent on alcohol also perform differently on behavioral tasks. Researchers
want to find out more about these differences. They also want to see if these differences are
related to DNA.
Objective:
- To see if differences in brain structure relate to personality and behavior differences in
people with and without alcohol dependence.
Eligibility:
- Adults age 18 and older.
Design:
- Participants will visit the NIH Clinical Center once during the study.
- Participants will be screened with a medical history, EKG, and physical exam. They will
give blood and urine samples and undergo a psychiatric interview.
- Participants will be asked about their alcohol drinking, to see if they have an alcohol
use disorder.
- Participants will play three computerized games. Some will play these games inside a
magnetic resonance imaging (MRI) scanner.
- MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie
on a table that slides in and out of a cylinder. They will be in the scanner for about
90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud
knocking noises. They will get earplugs.
- People with alcoholism have differences in their brains compared with healthy people.
People who are dependent on alcohol also perform differently on behavioral tasks. Researchers
want to find out more about these differences. They also want to see if these differences are
related to DNA.
Objective:
- To see if differences in brain structure relate to personality and behavior differences in
people with and without alcohol dependence.
Eligibility:
- Adults age 18 and older.
Design:
- Participants will visit the NIH Clinical Center once during the study.
- Participants will be screened with a medical history, EKG, and physical exam. They will
give blood and urine samples and undergo a psychiatric interview.
- Participants will be asked about their alcohol drinking, to see if they have an alcohol
use disorder.
- Participants will play three computerized games. Some will play these games inside a
magnetic resonance imaging (MRI) scanner.
- MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie
on a table that slides in and out of a cylinder. They will be in the scanner for about
90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud
knocking noises. They will get earplugs.
Objective: The purpose of this protocol is to obtain a standard set of assessments, including
brain behavioral, structural, functional, and connectivity (structural and functional)
information, on all NIAAA research participants, referred to hereinafter as Characterization
Imaging Instruments (CII); a) to determine how individual differences in brain structure and
evoked responses relate to generalized trait personality and behavior differences (as
assessed by psychometric questionnaire instruments and behavioral measures); and b) to
determine whether these individual differences relate specifically to genetic polymorphisms
in genes governing neurotransmitter activity. Thus, our goal of the CII is to identify the
brain structural, functional, behavioral, genetic, and other phenotypic factors that are
associated with alcoholism.
Study population: Non-treatment seeking adult volunteers and inpatient participants with
alcohol dependence (ADs). Inpatient ADs refer to individuals diagnosed as alcohol dependent
through DSM-IV-RT criteria or at least Moderate Alcohol Use Disorder as determined by DSM-5.
Design: This study will require one visit that will include an MRI scan (if the participant
is determined to be eligible for the scanner) consisting of a whole brain structural MRI,
Diffusion Tensor MRI, Resting State MRI (rsMRI) as well as several task-based functional
MRIs, while performing computerized behavioral, motivational, and cognitive/emotional tasks.
If the participant does not qualify for the MR scans, he/she will perform only the
computerized behavioral, motivational, and cognitive/emotional tasks outside the scanner.
These instruments include instruments in common with a similar protocol at NIDA.
Outcome measures: The outcome measures are differences in behavioral responses using standard
statistical methods, in brain structural data in blood oxygenation level dependent (BOLD)
signal measured using standard techniques and analyzed using established image analysis
approaches and software tools such as AFNI, SPM, FSL, DTI, Studio, etc. Secondary outcome
measures are to compare the genetic, behavioral and phenotypic factors to imaging and
behavioral data acquired across other protocols.
brain behavioral, structural, functional, and connectivity (structural and functional)
information, on all NIAAA research participants, referred to hereinafter as Characterization
Imaging Instruments (CII); a) to determine how individual differences in brain structure and
evoked responses relate to generalized trait personality and behavior differences (as
assessed by psychometric questionnaire instruments and behavioral measures); and b) to
determine whether these individual differences relate specifically to genetic polymorphisms
in genes governing neurotransmitter activity. Thus, our goal of the CII is to identify the
brain structural, functional, behavioral, genetic, and other phenotypic factors that are
associated with alcoholism.
Study population: Non-treatment seeking adult volunteers and inpatient participants with
alcohol dependence (ADs). Inpatient ADs refer to individuals diagnosed as alcohol dependent
through DSM-IV-RT criteria or at least Moderate Alcohol Use Disorder as determined by DSM-5.
Design: This study will require one visit that will include an MRI scan (if the participant
is determined to be eligible for the scanner) consisting of a whole brain structural MRI,
Diffusion Tensor MRI, Resting State MRI (rsMRI) as well as several task-based functional
MRIs, while performing computerized behavioral, motivational, and cognitive/emotional tasks.
If the participant does not qualify for the MR scans, he/she will perform only the
computerized behavioral, motivational, and cognitive/emotional tasks outside the scanner.
These instruments include instruments in common with a similar protocol at NIDA.
Outcome measures: The outcome measures are differences in behavioral responses using standard
statistical methods, in brain structural data in blood oxygenation level dependent (BOLD)
signal measured using standard techniques and analyzed using established image analysis
approaches and software tools such as AFNI, SPM, FSL, DTI, Studio, etc. Secondary outcome
measures are to compare the genetic, behavioral and phenotypic factors to imaging and
behavioral data acquired across other protocols.
- INCLUSION CRITERIA: ADULT PARTICIPANTS
All adult participants must have:
- Enrolled in screening protocol 14-AA-0181, Unit and Clinic Evaluation, Screening,
Assessment, and Management or have been determined eligible for another NIAAA study.
- Task performance (behavioral and fMRI) only: Are cleared based on neuromotor
examination as determined by the screening protocol 14-AA-0181.
EXCLUSION CRITERIA: ADULT PARTICIPANTS
- Exclusion criteria for MR scan
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of
the head (pacemakers or other implanted electrical devices, brain stimulators,
some types of dental implants, aneurysm clips, metallic prostheses, permanent
eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed
spaces. Eligibility will be determined by a "MRI Safety Screening Questionnaire"
and verified, if necessary, by a physician.
- Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner.
- Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel
discomfort in the scanner
- Women: Are pregnant
- Are left-handed.
- Inpatient participants with alcohol dependence who have symptoms of alcohol withdrawal
as indicated by the most recent measurement within the past 30 days, as measured by
the Clinical Institute Withdrawal Assessment (CIWA-Ar) score >= 8 (with sub-score more
than zero for orientation and more than 2 for all others).
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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