OEA for Young Adults With Alcohol Use Disorder

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 to 25.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • oleoylethanolamide

Treatment groups

42 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator