Health TrialsbyHealthPanel

OEA for Young Adults With Alcohol Use Disorder

ConditionAlcohol Use Disorder (AUD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 25.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: OEAExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and week 6
2

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

Time frame
Baseline and week 6
3

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

Time frame
Baseline and week 6
4

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

Time frame
Baseline and week 6

Secondary outcomes

1

Change in Oral Microbiome Alpha Diversity

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)

Time frame
Baseline and Week 6
2

Change in Oral Microbiome Beta Diversity

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)

Time frame
Baseline and Week 6
3

Change in Reward Sensitivity

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

Time frame
Baseline and Week 6
4

Change in Impulsivity

Impulsivity assessed using performance on the Delay Discounting Task, reflecting preference for smaller immediate versus larger delayed rewards. Unit of Measure: Discounting rate (k)

Time frame
Baseline and Week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: