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NCT04251221

Measuring the Neuroimmune Response to Alcohol

Completed EARLY_PHASE1 Results posted Last updated 7 November 2023
What this trial tests

EARLY_PHASE1 trial testing Oral Alcohol Challenge in Alcohol Drinking in 14 participants. Completed in 20 November 2021.

Timeline
20 June 2019
Primary endpoint
20 November 2021
20 November 2021

Quick facts

Lead sponsorYale University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment14
Start date20 June 2019
Primary completion20 November 2021
Estimated completion20 November 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

Adults 21 to 50, any sex, with Alcohol Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in [11C]PBR28 Distribution Volume After Alcohol Challenge. Primary · The post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. The total scan time for each imaging scan is 120 minutes long.

This is the percent change in \[11C\]PBR28 distribution volume (V\_T) post-alcohol relative to baseline. This is calculated as \[V\_T(Post-Alcohol) - V\_T(Baseline)\]/V\_T(Baseline) As a percent change, it could range from -10% to 200%.

GroupValue95% CI
Moderate Drinkers15.79± 8.00
Alcohol Use Disorder (AUD)6.36± 1.27

Sponsor's own description

This study uses positron emission tomography imaging of the 18-kDa translocator protein to measure the brain's immune response to alcohol.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Alcohol Drinking

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04251221.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing