NCT07503782

OEA for Young Adults With Alcohol Use Disorder

Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults With Alcohol Use Disorder

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DRUG	oleoylethanolamide	250 mg Oleoylethanolamide (OEA) administered daily for 6 weeks. OEA is an endogenous lipid mediator and peroxisome proliferator-activated receptor-alpha (PPAR-α) agonist being investigated for its potential effects on immune activation, oral microbiome composition, cognitive function, and alcohol use behavior in young adults with alcohol use disorder.

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-03-31
• Completion: 2031-03-31
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study