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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OEA | Experimental | Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide [OEA]) orally for 6 weeks. |
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| Placebo | Placebo Comparator | Participants receive a matching placebo capsule orally once daily for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and Week 6 |
| Change in Oral Microbiome Beta Diversity |
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Inclusion Criteria:
Call study team for additional screening and information.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C488250 | oleoylethanolamide |
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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 | Reward sensitivity assessed using the Behavioral Approach System (BAS) scale. Unit of Measure: Scale score | Baseline and Week 6 |
| 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) | Baseline and Week 6 |