Clinical Trial

OEA for Young Adults With Alcohol Use Disorder

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to evaluate the effects of oleoylethanolamide (OEA) supplementation on inflammation, the oral microbiome, neurocognitive function, and alcohol use in young adults ages 18 to 25 with alcohol use disorder (AUD). The main questions it aims to answer are: * Does OEA reduce peripheral markers of immune activation (IL-6, TNF-α, IL-1β, and LPS)? * Does OEA alter oral microbiome composition? * Does OEA improve neurocognitive measures of reward sensitivity and impulsivity? Researchers will compare OEA to a placebo (a look-alike substance with no active ingredient) to determine whether OEA improves biological and behavioral outcomes associated with AUD. Participants (N = 42) will: * Be randomly assigned to receive 300mg TRIPTI (providing 250 mg/day of OEA) or placebo for 6 weeks. * Provide blood, saliva, and urine samples * Complete cognitive testing and questionnaires * Report alcohol use during the study * Attend in-person study visits for monitoring and assessments This randomized, double-blind, placebo-controlled pilot trial will provide preliminary data on the potential efficacy of OEA as a multi-system intervention for young adults with AUD.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2031-03-31 -> 2031-06-01 2026-08-13
minor Completion pushed: 2031-03-31 -> 2031-06-01 2026-08-13
Trial Details
NCT Number NCT07503782
Lead Sponsor Medical University of South Carolina
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Use Disorder (AUD)
Enrollment 42 participants
Start Date 2026-11-01
Primary Completion 2031-06-01 (estimated)
Study Completion 2031-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-12