AlcoholismNCT03152760
Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
An observational study of Alcoholism, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Alcoholism
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 24 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- --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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Objective:
An increasing body of preclinical literature suggests a role of the gut microbiota in a wide range of medical disorders, including neuropsychiatric diseases like autism, anxiety, and depression. Preliminary studies have reported alterations in microbiota composition, inflammation, and intestinal permeability in alcohol-dependent patients. However, there is little research on the association between these alterations and behavioral outcomes associated with alcohol use disorder (AUD), such as alcohol craving and drinking. The main goal is to investigate gut microbiota differences in current drinking versus abstinent individuals with AUD, and whether microbial profiles are correlated with alcohol cue-induced craving. Finally, another goal of this project will be to conduct preliminary translational bed-to-bench work using rodent models of excessive alcohol use via collaborations with basic science laboratories.
Study population:
Alcohol use disorder participants (current drinkers and abstinent) and healthy controls.
Study Design:
Between subject, observational study
Outcome measures:
We will compare the gut microbiota of AUD participants who have been abstinent to that of current drinkers. In addition, we will further compare the gut microbiota of these two groups to a third group of healthy controls with no prior or current diagnosis of AUD. The secondary aim of this study is to examine whether the overall microbial community composition, function and individual taxa correlate with alcohol cue-induced craving.
- Conditions
- Alcoholism
- Keywords
- Alcoholism, Healthy Volunteers, Craving, Gut, Natural History
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abstinent Group (AB) | Current AUD diagnosis, currently abstaining from alcohol | |
| Current Drinking Group (CD) | Current AUD diagnosis, not seeking AUD treatment | |
| Healthy Control Group (HC) | NO current or past AUD diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed differences in composition and function of microbiome between cohorts
To investigate the primary aim, participants gut microbiota will be collected and analyzed to compare the three groups.
Measured: 10 day time frame
Secondary outcomes (1)
The secondary aims will be to examine whether participants' gut microbiota composition is associated with biobehavioral correlates as alcohol cue-induced craving during a Cue-reactivity procedure.
1.To examine whether participants' gut microbiota composition is associated with biobehavioral correlates as alcohol cue-induced craving during a Cue-reactivity procedure.
Measured: 10 day time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start28 Aug 2017
- Primary completion4 Mar 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Peter G. Dodge Foundation (PGDF)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Leggio, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152760
- Sponsor's protocol ID
- 170093
- Other IDs
- 17-DA-0093
- Status last verified
- 10 Aug 2026
- First submitted
- 12 May 2017
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share data and sample information with non-NIH researchers currently not involved in this protocol (as AIs or Collaborators) in several ways. First, we may develop partnerships with other researchers/collaborators. Non-NIH research collaborators sign agreements specifying what data can be shared, with whom and for what purposes. Second, we transfer de-identified information completely stripped of all PII into one or more scientific databases, where it will be stored with information obtained from other studies. This collaborative method facilitates effective and efficient sharing of scientific knowledge that may aid in better understanding health and disease for all researchers. Only researchers who have completed an application process to the database(s) may access this data for their individual research projects.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
- ClinicalTrials.gov ID
- NCT03152760
- Acronym / sponsor ID
- 170093
- Conditions
- Alcoholism
- Keywords
- Alcoholism, Healthy Volunteers, Craving, Gut, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- The Peter G. Dodge Foundation (PGDF)
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
An increasing body of preclinical literature suggests a role of the gut microbiota in a wide range of medical disorders, including neuropsychiatric diseases like autism, anxiety, and depression. Preliminary studies have reported alterations in microbiota composition, inflammation, and intestinal permeability in alcohol-dependent patients. However, there is little research on the association between these alterations and behavioral outcomes associated with alcohol use disorder (AUD), such as alcohol craving and drinking. The main goal is to investigate gut microbiota differences in current drinking versus abstinent individuals with AUD, and whether microbial profiles are correlated with alcohol cue-induced craving. Finally, another goal of this project will be to conduct preliminary translational bed-to-bench work using rodent models of excessive alcohol use via collaborations with basic science laboratories.
Study population:
Alcohol use disorder participants (current drinkers and abstinent) and healthy controls.
Study Design:
Between subject, observational study
Outcome measures:
We will compare the gut microbiota of AUD participants who have been abstinent to that of current drinkers. In addition, we will further compare the gut microbiota of these two groups to a third group of healthy controls with no prior or current diagnosis of AUD. The secondary aim of this study is to examine whether the overall microbial community composition, function and individual taxa correlate with alcohol cue-induced craving.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abstinent Group (AB) | – | –Current AUD diagnosis, currently abstaining from alcohol |
| Current Drinking Group (CD) | – | –Current AUD diagnosis, not seeking AUD treatment |
| Healthy Control Group (HC) | – | –NO current or past AUD diagnosis |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observed differences in composition and function of microbiome between cohorts
Time frame: 10 day time frame
To investigate the primary aim, participants gut microbiota will be collected and analyzed to compare the three groups.
1 secondary outcome
The secondary aims will be to examine whether participants' gut microbiota composition is associated with biobehavioral correlates as alcohol cue-induced craving during a Cue-reactivity procedure.
Time frame: 10 day time frame
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to share data and sample information with non-NIH researchers currently not involved in this protocol (as AIs or Collaborators) in several ways. First, we may develop partnerships with other researchers/collaborators. Non-NIH research collaborators sign agreements specifying what data can be shared, with whom and for what purposes. Second, we transfer de-identified information completely stripped of all PII into one or more scientific databases, where it will be stored with information obtained from other studies. This collaborative method facilitates effective and efficient sharing of scientific knowledge that may aid in better understanding health and disease for all researchers. Only researchers who have completed an application process to the database(s) may access this data for their individual research projects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Leggio, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed differences in composition and function of microbiome between cohorts (time frame: 10 day time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.