OEA for Young Adults With Alcohol Use Disorder

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07503782
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OEA
    Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide \[OEA\]) orally for 6 weeks.
  • Placebo Comparator: Placebo
    Participants receive a matching placebo capsule orally once daily for 6 weeks.

Primary Outcome Measure

Change in Peripheral IL-6 Concentration [ Time Frame: Baseline and week 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Cori Herring, BS
[email protected]
843-792-8207
Brittney Browning, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Medical University of South Carolina· Charleston, SC

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