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NCT Number: NCT07503782

OEA for Young Adults With Alcohol Use Disorder

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.

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location contact

Brittney Browning, PhD

PRINCIPAL_INVESTIGATOR

Cori Herring, BS

CONTACT

[email protected]

843-792-8207

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 25.

Call study team for additional screening and information.

Treatment and study plan

oleoylethanolamide

Drug

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.

Other names: TRIPTI, OEA

Primary outcomes

  1. Change in Peripheral IL-6 Concentration

    Time frame: Baseline and week 6

    Blood-based concentration of interleukin-6 (IL-6) measured using immunoassay methods to assess systemic inflammation. Unit of Measure: pg/mL

  2. Change in Peripheral TNF-α Concentration

    Time frame: Baseline and week 6

    Blood-based concentration of tumor necrosis factor-alpha (TNF-α) measured using immunoassay methods to assess systemic inflammation.Unit of Measure: pg/mL

  3. Change in Peripheral IL-1β Concentration

    Time frame: Baseline and week 6

    Blood-based concentration of interleukin-1 beta (IL-1β) measured using immunoassay methods to assess systemic inflammation. Unit of Measure: pg/mL

  4. Change in Plasma Lipopolysaccharide (LPS) Levels

    Time frame: Baseline and week 6

    Alpha diversity indices derived from sequencing of saliva samples to assess oral microbiome composition. Unit of Measure: pg/mL

Secondary outcomes

  1. Change in Oral Microbiome Alpha Diversity

    Time frame: Baseline and Week 6

    Alpha diversity indices (e.g., Shannon index, Simpson index, Pielou's evenness) derived from sequencing of saliva samples to assess within-sample oral microbiome diversity. Unit of Measure: Unitless (diversity indices)

  2. Change in Oral Microbiome Beta Diversity

    Time frame: Baseline and Week 6

    Beta diversity metrics (e.g., Bray-Curtis dissimilarity, Jaccard distance) derived from sequencing of saliva samples to assess between-sample variation in oral microbiome composition. Unit of Measure: Unitless (distance/dissimilarity metrics)

  3. Change in Reward Sensitivity

    Time frame: Baseline and Week 6

    Reward sensitivity assessed using the Behavioral Approach System (BAS) scale. Unit of Measure: Scale score

  4. Change in Impulsivity

    Time frame: Baseline and Week 6

    Impulsivity assessed using performance on the Delay Discounting Task, reflecting preference for smaller immediate versus larger delayed rewards.

    Unit of Measure: Discounting rate (k)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 31, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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