OEA for Young Adults With Alcohol Use Disorder

Medical University of South Carolina (MUSC)

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Alcohol Use Disorder (AUD)

Treatments: Drug: oleoylethanolamide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07503782

Pro00149840

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 18 to 25.

Call study team for additional screening and information.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

OEA

Experimental group

Description:

Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide \[OEA\]) orally for 6 weeks.

Treatment:

Drug: oleoylethanolamide

Placebo

Placebo Comparator group

Description:

Participants receive a matching placebo capsule orally once daily for 6 weeks.

Treatment:

Drug: oleoylethanolamide