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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: Completed Early Phase 1 study of Alcohol Use Disorder (AUD), sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess if there is neuroinflammation detected in the brain of alcoholics subjects as measured with \[11C\]PBR28 as compared to healthy controls and if it recovers with at least 3 weeks of abstinence.
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 |
What the finished NCT02233868 record still lists
NCT02233868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 1,821-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder (AUD)
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 NCT02233868's enrollment target sits among peer trials
74 19th of 30 higher than 12 of 30 other Alcohol Use Disorder (AUD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder (AUD) 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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