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Brain Inflammation and Function in Alcoholism
NCT02233868 · View on ClinicalTrials.gov ↗
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
Interventions
- OTHER connectivity
- DRUG neuroinflammation
- OTHER neurofunction
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2015-02-19 |
| Est. Completion | 2021-08-16 |
| Phase | Early Phase 1 |
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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. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02233868 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02233868?
The interventions under investigation include: connectivity (OTHER), neuroinflammation (DRUG), neurofunction (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02233868?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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