OEA for Young Adults With Alcohol Use Disorder

March 26, 2026 updated by: Medical University of South Carolina

Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Brittney Browning, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 to 25.

Call study team for additional screening and information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OEA
Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide [OEA]) orally for 6 weeks.
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.
Other Names:
  • TRIPTI
  • OEA
Placebo Comparator: Placebo
Participants receive a matching placebo capsule orally once daily for 6 weeks.
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.
Other Names:
  • TRIPTI
  • OEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and week 6
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
Baseline and week 6
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
Baseline and week 6
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
Baseline and week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and Week 6
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)
Baseline and Week 6
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
Baseline and Week 6
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)
Baseline and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 31, 2031

Study Completion (Estimated)

March 31, 2031

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00149840

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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