Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults With Alcohol Use Disorder
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in Peripheral IL-6 Concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 to
- •Call study team for additional screening and information.
Exclusion Criteria
- Not provided
Arms & Interventions
OEA
Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide [OEA]) orally for 6 weeks.
Intervention: oleoylethanolamide (Drug)
Placebo
Participants receive a matching placebo capsule orally once daily for 6 weeks.
Intervention: oleoylethanolamide (Drug)
Outcomes
Primary Outcomes
Change in Peripheral IL-6 Concentration
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and week 6
Alpha diversity indices derived from sequencing of saliva samples to assess oral microbiome composition. Unit of Measure: pg/mL
Secondary Outcomes
- 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)
Investigators
Brittney Browning
Assistant Professor-Faculty
Medical University of South Carolina