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NCT02233868 · ClinicalTrials.gov registry record · Early Phase 1

Brain Inflammation and Function in Alcoholism

A Early Phase 1 study of Alcohol Use Disorder (AUD), sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
Early Phase 1
Development phase
74
Enrollment target
1
Study location

NCT02233868 is a Early Phase 1 study of Alcohol Use Disorder (AUD) that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 74 participants, below the 1,821-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02233868, a Early Phase 1 study of Alcohol Use Disorder (AUD), has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
Early Phase 1
Development phase
74 participants
Enrollment target
1
Study location

Study Summary

Background: \- Brain inflammation due to high alcohol intake may affect thinking, memory, and concentration. Researchers want to measure this using positron emission tomography (PET). Objective: \- To study how excessive alcohol consumption affects brain function. Eligibility: * Adults 30-75 years old who are moderate or severe alcohol drinkers. * Healthy volunteers. Design: * Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking. * Phase 1: * Participants will stay in the hospital 3 days. They will have blood and heart tests and daily urine tests. * A small plastic tube will be inserted by needle in each arm. One will go in a vein, the other in an artery. * Participants will have 2 PET scans with 2 different radioactive compounds. Participants will lie on a bed that slides in and out of the scanner with a cap on their head. * Participants will have magnetic resonance imaging (MRI) scans. Participants will lie in the scanner either resting with their eyes open or while performing an attention task. * Participants will have tests of memory, attention, concentration, and thinking. They may answer questions, take tests, and perform simple actions. * Phase 2 of the study will only be done if Phase 1 results show brain inflammation. * Phase 2 will repeat Phase 1. * For healthy volunteers, Phase 2 will begin 3 weeks after Phase 1. * Other volunteers must not have alcohol for at least 3 weeks and stay in a hospital up to 4-6 weeks between Phase 1 and Phase 2. After Phase 2, they will have 5 follow-up calls over 3 months.

Conditions Studied

Alcohol Use Disorder (AUD)

Interventions

  • OTHER connectivity
  • DRUG neuroinflammation
  • OTHER neurofunction

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2015-02-19
Est. Completion 2021-08-16
Phase Early Phase 1

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

93 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02233868

The ClinicalTrials.gov registry entry for NCT02233868 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,821-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (96% lower). The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol Use Disorder (AUD) appearing as the primary indexed condition, and to 3 interventions - of which connectivity is the first listed.

NCT02233868 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02233868 about?

NCT02233868 is a clinical study titled "Brain Inflammation and Function in Alcoholism". Background: \- Brain inflammation due to high alcohol intake may affect thinking, memory, and concentration. Researchers want to measure this using positron emission tomography (PET). Objective: \- To study how excessive alcohol consumption affects brain function. Eligibility: * Adults 30-75 ye...

What is the current status of trial NCT02233868?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 74 participants. The study started on 2015-02-19. Estimated completion is 2021-08-16.

What conditions does trial NCT02233868 study?

This clinical trial studies the following conditions: Alcohol Use Disorder (AUD).

What interventions are being tested in trial NCT02233868?

The interventions under investigation include: connectivity (OTHER), neuroinflammation (DRUG), neurofunction (OTHER).

Who is sponsoring clinical trial NCT02233868?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02233868 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.