Brain Inflammation and Function in Alcoholism

NCT02233868 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Alcohol Use Disorder (AUD)

Interventions

OTHER

connectivity

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

DRUG

neuroinflammation

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.

OTHER

neurofunction

To assess regional brain glucose metabolism.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Dardo G Tomasi, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-19
Primary Completion
2021-08-16
Completion
2021-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233868 on ClinicalTrials.gov