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Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study

NCT03152760 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2026-04-08

No results posted yet for this study

Summary

Background:

Alcohol use disorder (AUD) affects about 10 percent of people in the U.S. Studies show a relationship between the bacteria (microbiota) in the gut and the brain. Researchers think this may influence AUD. They want to learn more about changes in gut bacteria that may occur in people with AUD.

Objectives:

To study gut microbiota differences in current drinking versus abstinent people with AUD. Also to test if gut microbiota are related to alcohol cue-induced craving.

Eligibility:

People ages 21-70 who have AUD (both abstinent and current heavy drinkers) or are healthy, moderate drinkers

Design:

Participants will be screened in Protocol 14-AA-0181.

Participants will have a first visit. They will have 4 more visits within about 10 days. Visits include:

Fecal sample collection

Physical exam

Blood tests

Assessment of diet and alcohol use

X-rays to test body composition,

They will sit under a ventilation hood to measure metabolism. They must fast 12 hours before this test.

They will drink a solution. Their urine is collected over 5 hours.

Ultrasound of the liver area. They must fast overnight before this test.

At 2 visits, they will be in a bar-like setting. They will be exposed to stimuli associated with eating and drinking. They will rate their urge to drink alcohol and their food cravings.

Participants will collect their stool throughout the study. They will also record information about their diet and daily activities like sleep and exercise.

At the end of the study, participants will discuss their drinking. They will receive counseling if needed.

Conditions

  • Alcoholism

Sponsors & Collaborators

  • The Peter G. Dodge Foundation (PGDF)

    collaborator UNKNOWN

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Lorenzo Leggio, M.D. · National Institute on Drug Abuse (NIDA)

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2020-03-04
Completion
2020-11-24

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 NCT03152760 on ClinicalTrials.gov