Clinical trial NCT02564991: Study of Structural Imaging
Official title: Cross-Sectional and Longitudinal Study of Structural Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemically-Induced Disorders
Substance-Related Disorders
Mental Disorders
Alcohol Dependence
Alcohol-Related Disorders
Keywords: Alcoholism
MRI
Structural MRI
Cerebellum
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2015-10-01
Enrollment: 98
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and Inpatient participants with alcohol use disorders. . Design Participants will receive whole-brain structural imaging and assessment of cerebellar function at the time of admission and again at the time of discharge

Brief summary: Background:

The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. They hope this will help them better understand changes that happen in brain regions during treatment of alcohol use disorders.

Objectives:

To study changes in the brain by using MRI in people with and without alcohol use disorders. To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how the brain recovers when alcohol use stops.

Eligibility:

People with alcohol dependence who are currently hospitalized in a particular unit at NIH.

Healthy volunteers 30 60 years old without an alcohol use disorder.

Design:

Participants will be screened under a separate protocol.

Participants will give a urine sample for a drug test and pregnancy test at each study visit. They will also have to pass a breath alcohol test.

At the first visit, participants will have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.

They will do behavior and memory tasks outside the scanner.

They will have gait and balance tested. They will have to stand on both legs, stand on just one leg, and walk in a straight line. They will perform each task with eyes open, then with eyes closed.

They will have tests of memory, thinking, and problem solving.

Some participants will have a second visit. They will have another MRI and repeat some of the behavior and memory tasks.

...

Detailed description: Objective

The purpose of this protocol is to characterize cerebellar volumes and function in alcoholics and recovery of cerebellar volume and function during early abstinence. This study also investigates how cerebrocerebellar circuits contribute to cognitive and motor impairment in alcoholism.

Study Population

Healthy volunteers and Inpatient participants with alcohol use disorders.

Design

Participants will receive whole-brain structural imaging and assessment of cerebellar function at the time of admission and again at the time of discharge.

Outcome

The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.

Eligibility criteria: * INCLUSION CRITERIA:

  1. 30 to 60 years old
  2. Physically healthy
  3. Healthy volunteers only: Currently consuming 7 or less standard drinks per week if female; 14 or less drinks per week if male.

EXCLUSION CRITERIA:

1. Significant history of head trauma or cranial surgery,
2. History of diabetes or stroke which requires medical intervention,
3. Clinical or laboratory evidence of severe hepatic disease as determined by ALT or AST greater than 5 times the upper normal limit, INR greater than 2.0, total bilirubin greater than 2.5 mg/dL, and albumin lower than 3.0 g/dL.
4. Positive HIV test.
5. Healthy volunteers only: 5 or more binge drinking episodes in the past 30 days (5 or more standard drinks on one occasion for males, 4 or more standard drinks on one occasion for females within two hours)
6. Healthy volunteers only:

   --Have fulfilled DSM-IV or DSM-5 criteria for current alcohol use disorder or substance abuse disorder
7. Inpatient participants only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the past 30 days CIWA score \> 8)
8. Female participants only: Are currently pregnant
9. IPresence of any contraindication for fMRI as determined by the NIAAA MRI Safety Screening Questionnaire
10. Have calustrophobia

Primary outcomes:
measure: The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.
timeFrame: Entry and End of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Reza Momenan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: