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NCT03152760 · ClinicalTrials.gov registry record
Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
A clinical trial of Alcoholism, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- 35
- Enrollment target
- 1
- Study location
NCT03152760: Completed study of Alcoholism, sponsored by National Institute on Drug Abuse (NIDA).
NCT03152760 is a study of Alcoholism that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 35 participants, below the 375-participant average among 65 other Alcoholism trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03152760, a study of Alcoholism, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To investigate the primary aim, participants gut microbiota will be collected and analyzed to compare the three groups.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2020-11-24 |
What the finished NCT03152760 record still lists
NCT03152760 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 375-participant average among 65 other Alcoholism trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 0 interventions.
NCT03152760 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03152760 about?
NCT03152760 is a clinical study titled "Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot 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...
What is the current status of trial NCT03152760?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2017-08-28. Estimated completion is 2020-11-24.
What conditions does trial NCT03152760 study?
This clinical trial studies the following conditions: Alcoholism.
Who is sponsoring clinical trial NCT03152760?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03152760 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03152760's enrollment target sits among peer trials
35 60th of 65 higher than 5 of 65 other Alcoholism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcoholism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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