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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute on Drug Abuse (NIDA)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 21 Years
Max Age: 70 Years

Referral Letter Required


Population Exclusion(s)



Healthy Volunteers;
Natural History

Recruitment Keyword(s)




Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute on Drug AbuseThe Peter G. Dodge Foundation (PGDF)


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.


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.


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


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.

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-Male or female individuals 21-70 years old (inclusive)

Specific For Abstinent Group; AB

-Current Alcohol Use Disorder (AUD) by DSM-5 criteria

-Being alcohol abstinent for at least 4 weeks, with a minimum of 2 weeks in a non-protective environment at the time of study screening.

Specific For Current Drinking Group; CD

-Current Alcohol Use Disorder (AUD) by DSM-5 criteria

-Participants not seeking treatment for their alcohol use will be included.

-Satisfying heavy drinking criteria during the 4-weeks prior to screening (i.e., for men, >14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, >7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days) and any drinking during the 2-day prior to signing the study-specific consent.

Specific For Healthy Control Group; HC

-No current or past diagnostic of AUD by DSM-5 criteria

-Moderate alcohol consumers: i.e., up to 1 drink per day on average and not meeting NIAAA criteria for:

- -heavy (i.e., for men, >14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, >7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days)

- -or binge drinking (i.e., drinking 5 or more standard drinks on the same occasion on at least 1 day in the past 30 days for both male and female)

If any answer is No , subject may not be enrolled.


Exclusion - All Participants (at the time subject are evaluated for this protocol)

-Current pregnancy or lactation

-Positive Urine Drug Test for illegal drugs

-Body Mass Index (BMI) less than or equal to 18.5 kg/m(2) or BMI greater than or equal to 40 kg/m(2)

-Presence of active implantable electronic devices (e.g., defribillators, pumps, pacemakers)

-Current medical history of the following medical conditions:

--diabetes; chronic gut inflammatory diseases; GI or any other type of cancer; short bowel syndrome; conditions requiring parenteral nutrition;

-Diarrhea or other symptoms of possible enteritis in the past 7 days (self-reported)

-Recent history of sigmoidoscopy or colonoscopy (past 30 days)

-Current use (past 90 days) of the following medications:

--oral antimicrobials (specifcally: antiviral, antifungal, or antibiotics); prebiotics; probiotics; laxatives; antispasmodic drugs; oral, IM or IV steroids

-Any other reason or clinical condition that the PI, or Medical Advisory Investigator (MAI) considers unsafe or not in the best interest of the study research integrity

If any answer is Yes , subject may not be enrolled.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Lorenzo Leggio, M.D.
National Institute on Drug Abuse (NIDA)
(240) 478-1503

NIDA IRP Screening Team
National Institute on Drug Abuse (NIDA)

(800) 535-8254

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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