Oleoylethanolamide for Alcoholism
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 300mg TRIPTI (providing 250 mg/day of OEA) or placebo for 6 weeks. They provide blood, saliva, and urine samples, complete cognitive testing and questionnaires, and report alcohol use.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oleoylethanolamide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide \[OEA\]) orally for 6 weeks.
Participants receive a matching placebo capsule orally once daily for 6 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
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