Alcohol Use Disorder (AUD)
Conditions
Keywords
OEA, oleoylethanolamide, AUD, Oral microbiome, Alcohol
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.
Interventions
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.
Sponsors
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 25. Call study team for additional screening and information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peripheral IL-6 Concentration | 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 |
| Change in Peripheral TNF-α Concentration | 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 |
| Change in Peripheral IL-1β Concentration | 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 |
| Change in Plasma Lipopolysaccharide (LPS) Levels | Baseline and week 6 | Alpha diversity indices derived from sequencing of saliva samples to assess oral microbiome composition. Unit of Measure: pg/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Microbiome Alpha Diversity | 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) |
| Change in Oral Microbiome Beta Diversity | 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) |
| Change in Reward Sensitivity | Baseline and Week 6 | Reward sensitivity assessed using the Behavioral Approach System (BAS) scale. Unit of Measure: Scale score |
| Change in Impulsivity | 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) |
Countries
United States
Outcome results
None listed