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Report for Clinical Trial NCT02233868

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Brain Inflammation and Function in Alcoholism

Background: - Brain inflammation due to high alcohol intake may affect thinking, memory, and concentration. Researchers want to measure this using positron emission tomography (PET). Objective: - To study how excessive alcohol consumption affects brain function. Eligibility: - Adults 30-75 years old who are moderate or severe alcohol drinkers. - Healthy volunteers. Design: - Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking. - Phase 1: - Participants will stay in the hospital 3 days. They will have blood and heart tests and daily urine tests. - A small plastic tube will be inserted by needle in each arm. One will go in a vein, the other in an artery. - Participants will have 2 PET scans with 2 different radioactive compounds. Participants will lie on a bed that slides in and out of the scanner with a cap on their head. - Participants will have magnetic resonance imaging (MRI) scans. Participants will lie in the scanner either resting with their eyes open or while performing an attention task. - Participants will have tests of memory, attention, concentration, and thinking. They may answer questions, take tests, and perform simple actions. - Phase 2 of the study will only be done if Phase 1 results show brain inflammation. - Phase 2 will repeat Phase 1. - For healthy volunteers, Phase 2 will begin 3 weeks after Phase 1. - Other volunteers must not have alcohol for at least 3 weeks and stay in a hospital up to 4-6 weeks between Phase 1 and Phase 2. After Phase 2, they will have 5 follow-up calls over 3 months.

NCT02233868 Alcohol Use Disorder (AUD)
MeSH:Encephalitis Inflammation Alcoholism Alcohol Drinking

3 Interventions

Name: connectivity

Description: Magnetic resonance imaging (MRI) scans will be done to assess brain structure, functional reactivity and functional connectivity.
Type: Other

Name: neuroinflammation

Description: The use of [11C] PBR28 will allow us to assess for the first time in vivo if there is neuroinflammation in the brain of alcoholics. It will also allow us to assess if it recovers with alcohol detoxification.
Type: Other

Name: neurofunction

Description: To assess regional brain glucose metabolism.
Type: Drug

Primary Outcomes

Description: To assess if there is inflammation detected in the brain of alcoholics subjects as measured with [11C]PBR28 as compared to healthy controls.

Measure: To assess inflammation in the brain

Time: end of study

Description: To assess if there is neuroinflammation detected in the brain of alcoholics subjects as measured with [11C]PBR28 as compared to healthy controls and if it recovers with at least 3 weeks of abstinence.

Measure: To determine if there is neuroinflammation in the brain.

Time: end of study

Description: We want to see whether [11C] PBR28 uptake in the brain reflects levels similar to controls after at least 3 weeks of alcohol abstinence.

Measure: To assess between group differences in inflammation in the brain of AUD subjects in Phase II who either abstain from alcohol for at least 3 weeks or relapse (continue to drink alcohol) for at least 3 weeks.

Time: end of study

Secondary Outcomes

Description: to assess if neuroinflammation is associated with markers of brain function and to evaluate if neuroinflammation predicts relapse in AUD over a 3 month follow-up period.

Measure: To assess the impact of neuroinflammation on brain function (assessed with PET and 18FDG and with MRI for fMRI with task activation and for functional connectivity).

Time: end of study

Purpose: Basic Science

Parallel Assignment

There is one SNP


1 rs6971

Homozygosity for the rs6971 polymorphism on TSPO that results in LB (Owen et al 2011) (genotyping results).

HPO Nodes