Oleoylethanolamide for Alcoholism

Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical University of South Carolina
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement called oleoylethanolamide (OEA) can assist young adults with alcohol use disorder (AUD) by influencing inflammation, the oral microbiome (the community of bacteria in the mouth), brain functions related to decision-making, and alcohol consumption habits. Participants will take either OEA or a placebo (a non-active substance) for six weeks. The study aims to determine if OEA can induce positive changes in the body and behavior for those struggling with AUD. Individuals aged 18 to 25 who regularly consume alcohol might be suitable candidates for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to contact the study team for more details.

Is there any evidence suggesting that oleoylethanolamide is likely to be safe for humans?

Research shows that oleoylethanolamide (OEA) is generally safe for people. Previous studies indicate that humans tolerate OEA well. This compound reduces inflammation and protects against damage in both the brain and body. A thorough safety review found that OEA manages inflammation and stress without causing major side effects.

Evidence from earlier research shows that OEA can reduce alcohol consumption in animal studies, suggesting its safety. Importantly, at least one human trial tested OEA in young adults with alcohol use disorder, and no major safety issues emerged.

Overall, current data suggests that OEA is safe for humans, especially in the doses likely used in clinical trials. Researchers will continue to monitor its safety during the trial to ensure it remains safe in this new setting.12345

Why do researchers think this study treatment might be promising?

Oleoylethanolamide (OEA) is unique because it targets the body's endocannabinoid system, which plays a role in regulating addiction and cravings. Unlike traditional treatments for alcoholism, such as disulfiram or naltrexone, which mainly focus on altering alcohol metabolism or blocking the pleasurable effects of alcohol, OEA is thought to help reduce the urge to drink by influencing appetite and reward pathways. Researchers are excited about OEA because it offers a potential new mechanism of action, possibly providing an alternative for individuals who do not respond well to existing therapies.

What evidence suggests that oleoylethanolamide might be an effective treatment for alcohol use disorder?

Research suggests that oleoylethanolamide (OEA), which participants in this trial may receive, might help reduce drinking and its harmful effects. Studies have shown that OEA acts as a strong anti-inflammatory, potentially protecting the brain from damage caused by heavy drinking. It may also help control the urge to drink by influencing how the brain processes rewards. In early tests, OEA lowered alcohol intake by altering how the body handles stress. Overall, initial findings indicate that OEA could be helpful in managing alcohol use disorder.12346

Are You a Good Fit for This Trial?

This trial is for young adults ages 18 to 25 who have been diagnosed with alcohol use disorder. Participants must meet basic health requirements and be willing to attend study visits and provide samples.

Inclusion Criteria

I am between 18 and 25 years old.
Call study team for additional screening and information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 weeks
Multiple in-person visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Oleoylethanolamide

Trial Overview

The study tests whether a supplement called oleoylethanolamide (OEA) can improve inflammation, oral bacteria balance, thinking skills, and drinking habits in young adults with alcohol use disorder. OEA is compared to a placebo over six weeks in a randomized, double-blind design.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: OEAExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Citations

Oleoylethanolamide, Neuroinflammation, and Alcohol Abuse

Preclinical studies have shown that OEA is a potent anti-inflammatory and antioxidant compound that exerts neuroprotective effects in alcohol abuse.

OEA for Young Adults With Alcohol Use Disorder

The goal of this clinical trial is to evaluate the effects of oleoylethanolamide (OEA) supplementation on inflammation, the oral microbiome, neurocognitive ...

Oleoylethanolamide effects on stress-induced alcohol ...

We observed that a multiple-dose chronic OEA treatment was effective in reducing alcohol consumption during the FR1 period. ... Psychiatric ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26037332/

Role of the satiety factor oleoylethanolamide in alcoholism

Oleoylethanolamide (OEA) is a satiety factor that controls motivational responses to dietary fat. Here we show that alcohol administration causes the release of ...

Mechanisms of Central and Peripheral Action.

Alcohol use disorder (AUD) is a complex disease whose pathogenesis involves profound neurobiological disturbances in reward, stress, ...

Effects of Alcohol Binge Drinking and Oleoylethanolamide ...

Alcohol binge drinking reduced the richness of the gut microbiota and changed the microbial community, reducing Lactobacillus among other genera.