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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 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.

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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.

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2017-08-28
Est. Completion 2020-11-24

What the Registry Record Tells You About NCT03152760

The ClinicalTrials.gov registry entry for NCT03152760 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 375-participant average among 65 other Alcoholism trials with a reported enrollment target (91% lower). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 0 interventions.

NCT03152760 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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