Characterization Imaging Instruments in Alcoholics and Non-Alcoholics

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT02108080

Collaborator

(none)

1,000

Enrollment

Location

137.7

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

Characterization Imaging Instruments for Addiction Neuroimaging Assessments

Actual Study Start Date :

Jul 10, 2014

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Inpatient AUD This group includes individuals who are in the alcohol use treatment.
Outpatient This group includes individuals who are not seeking treatment for alcohol use disorder.

Outcome Measures

Primary Outcome Measures

Addiction Neuroimaging Assessments & blood oxygenation level [Multiple sessions]
Outcome measures of interest include differences in brain structural data and in blood oxygenation level dependent (BOLD) signals collected cross-sectionally and /or longitudinally at various stages of alcohol use disorder
Addiction Neuroimaging Assessments [Multiple sessions]
structural and functional connectivity in salience, default mode, and executive control networks

Secondary Outcome Measures

AFNI, FSL, SPM and FreeSurfer software [MRI STUDY VISIT]
Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other protocols

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

All adult participants must be:

Age 18 years or older,
Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any

NIAAA study (including 14-AA-0181).

EXCLUSION CRITERIA:

As this is a natural history protocol, there are no exclusionary criteria for this study.

Participants should have been tested negative at the time of consent and study procedures using an alcohol breathalyzer, Individuals with a positive breath alcohol concentration (BrAC) will be re-scheduled or withdrawn from the study.

Upon completion of the consent, the participant will be invited for the study session. On the study session day, the following exclusion criteria will be applied.

-Exclusion criteria for MR scan*

Positive BrAC#,
Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, opiates and tetrahydrocannabinol (THC) for outpatients. Positive UDT for benzodiazepines and THC are not exclusionary for the inpatients. It is common that the inpatients who are treated for AUD withdrawal are treated with benzodiazepines. Positive THC would also not be exclusionary for this study since it tends to be detected over the long period of time after use. However, we will make note of these for the data analysis purposes.
Task performance (behavioral, fMRI) only: cleared based on neuromotor examination,
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),
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 use disorder who have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, measured by the Clinical Institute Withdrawal Assessment (CIWA-Ar) score >= 8.
Subjects excluded from MR scan may still perform the behavioral tasks which would otherwise be performed in the scanner, if they qualify for behavioral tasks. To avoid undue discomfort, burden, and inconvenience this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data.
Participants who meet this exclusion criterion will not participate in any part of this study at the time. They will be re-scheduled for a future date(s) when they do not meet any of the exclusionary criterion.