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

NCT03152760 | Completed

• 2 other identifiers: 17009317-DA-0093
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alcoholism; Healthy Volunteers; Craving; Gut; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  10 day time frame

Study Arms (3)

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

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• The Peter G. Dodge Foundation (PGDF): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lorenzo Leggio, M.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: August 28, 2017
• Primary Completion: March 4, 2020
• Study Completion: November 24, 2020
• Last Updated: April 8, 2026

Record last verified: 2026-03-24

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD information will be available approximately one year following publication
• Access Criteria: 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.

Locations

US (1)