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Characterization Imaging Instruments in Alcoholics and Non-Alcoholics

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ClinicalTrials.gov Identifier: NCT02108080
Recruitment Status : Recruiting
First Posted : April 9, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )

Brief Summary:

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.

Condition or disease
Alcohol Dependence Alcohol Drinking Alcohol-Related Disorders Alcoholism Brain Mapping

Detailed Description:

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 using AFNI, FSL, SPM and FreeSurfer software, and in blood oxygenation level dependent (BOLD) signal measured using standard fMRI techniques and analyzed using AFNI and FSL software. Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other protocols.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Other
Official Title: Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
Study Start Date : April 8, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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... [ Time Frame: ongoing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108080


Contacts
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Contact: Reza Momenan, Ph.D. (301) 451-6972 rezam@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Reza Momenan, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Additional Information:
Publications:
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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT02108080     History of Changes
Other Study ID Numbers: 140080
14-AA-0080
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: September 24, 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ):
Alcohol
Adolescents
Adults

Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior