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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
HPO:Encephalitis
3 Interventions
Name: connectivity
Name: neuroinflammation
Name: neurofunction
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 studyDescription: 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 studyDescription: 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 studySecondary 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 studyPurpose: Basic Science
Parallel Assignment
There is one SNP
SNPs
1 rs6971
Homozygosity for the rs6971 polymorphism on TSPO that results in LB (Owen et al 2011) (genotyping results).