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Gut bacteria may influence alcohol cravings, new study suggests

NCT ID NCT03152760

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 5 times

Summary

This study explores the link between gut bacteria and alcohol use disorder (AUD). Researchers compared gut microbiota in three groups: current heavy drinkers with AUD, people with AUD who have been abstinent for at least 4 weeks, and healthy moderate drinkers. Participants provided stool samples, underwent physical exams, and took part in cue-reactivity sessions in a bar-like setting to measure cravings. The goal is to understand if gut bacteria differ between these groups and if they relate to alcohol cravings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how gut bacteria influence alcohol cravings, pointing toward new ways to treat alcohol use disorder.
What could go wrong
This is a small pilot study with only 35 participants, so results may not apply to everyone. It is designed to gather information, not to test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

35 people

The number who actually took part.

Started

Aug 2017

Finished

Nov 2020

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Male or female individuals 21-70 years old Individuals may come to the NIH/NIAAA from a variety of community settings ranging from primary residences, shelters and/or other health care facilities

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * 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 CRITERIA: 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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.