NCT03152760|Completed
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Sponsor study identifier
Secondary identifiers
observational
35
1 country
1
Study Start
August 28, 2017
Actual (reported)Primary Completion
March 4, 2020
Actual (reported)Study Completion
November 24, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 24, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2017
Actual (reported)May 15, 2017
Actual (reported)August 28, 2017
Actual (reported)March 4, 2020
Actual (reported)November 24, 2020
Actual (reported)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
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
Current AUD diagnosis, currently abstaining from alcohol
Current AUD diagnosis, not seeking AUD treatment
NO current or past AUD diagnosis
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Lorenzo Leggio, M.D.
National Institute on Drug Abuse (NIDA)
35 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2017
First Posted
May 15, 2017
Study Start
August 28, 2017
Actual (reported)Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
Contact the study team to confirm eligibility.
Primary Completion
March 4, 2020
Actual (reported)Study Completion
November 24, 2020
Actual (reported)Last Updated
August 12, 2026
Record last verified: 2026-08-10
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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Source: ClinicalTrials.gov.
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