NCT07503782

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
59mo left

Started Jun 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Mar 2031

First Submitted

Initial submission to the registry

March 3, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

March 3, 2026

Last Update Submit

March 26, 2026

Conditions

Alcohol Use Disorder (AUD)

Keywords

OEAoleoylethanolamideAUDOral microbiomeAlcohol

Outcome Measures

Primary Outcomes (4)

  • Change in Peripheral IL-6 Concentration

    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

    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

    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

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

    Baseline and week 6

Secondary Outcomes (4)

  • Change in Oral Microbiome Alpha Diversity

    Baseline and Week 6

  • Change in Oral Microbiome Beta Diversity

    Baseline and Week 6

  • Change in Reward Sensitivity

    Baseline and Week 6

  • Change in Impulsivity

    Baseline and Week 6

Study Arms (2)

OEA

EXPERIMENTAL

Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide \[OEA\]) orally for 6 weeks.

Drug: oleoylethanolamide

Placebo

PLACEBO COMPARATOR

Participants receive a matching placebo capsule orally once daily for 6 weeks.

Drug: oleoylethanolamide

Interventions

oleoylethanolamideDRUG

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.

Also known as: TRIPTI, OEA
OEAPlacebo

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 25.
  • Call study team for additional screening and information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

oleoylethanolamide

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 31, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

March 31, 2031

Study Completion (Estimated)

March 31, 2031

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

US(1)