Alcohol Use Disorder (AUD)Phase 2NCT07503782
OEA for Young Adults With Alcohol Use Disorder
A Phase 2 study testing oleoylethanolamide in people with Alcohol Use Disorder (AUD), run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- oleoylethanolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jun 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 25.
- Call study team for additional screening and information.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
Cori Herring, BS, 843-792-8207, herrinco@musc.edu
Brittney Browning, PhD
About this study
Official title: Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic 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 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?
Read more
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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- oleoylethanolamide
- Keywords
- OEA, oleoylethanolamide, AUD, Oral microbiome, Alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oleoylethanolamideDrug
Also called TRIPTI, OEA
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.
| Study group | Role | What they receive |
|---|---|---|
| OEA | Experimental | Participants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide [OEA]) orally for 6 weeks. Receives: Drug: oleoylethanolamide |
| Placebo | Placebo comparator | Participants receive a matching placebo capsule orally once daily for 6 weeks. Receives: Drug: oleoylethanolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and week 6
Secondary outcomes (4)
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)
Measured: Baseline and Week 6
Change in Oral Microbiome Beta Diversity
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)
Measured: Baseline and Week 6
Change in Reward Sensitivity
Reward sensitivity assessed using the Behavioral Approach System (BAS) scale. Unit of Measure: Scale score
Measured: 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)
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Brittney Browning, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503782
- Sponsor's protocol ID
- Pro00149840
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07503782
- Acronym / sponsor ID
- Pro00149840
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- OEA, oleoylethanolamide, AUD, Oral microbiome, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OEA | Experimental | Drug: oleoylethanolamideParticipants receive 300mg TRIPTI a day (providing 250 mg/day oleoylethanolamide [OEA]) orally for 6 weeks. |
| Placebo | Placebo comparator | Drug: oleoylethanolamideParticipants receive a matching placebo capsule orally once daily for 6 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 25.
- Call study team for additional screening and information.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oleoylethanolamideAlso: TRIPTI, OEA250 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. | Drug | OEA, Placebo |
Primary outcome
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
4 secondary outcomes
Change in Oral Microbiome Alpha Diversity
Time frame: Baseline and Week 6
Change in Oral Microbiome Beta Diversity
Time frame: Baseline and Week 6
Change in Reward Sensitivity
Time frame: Baseline and Week 6
Change in Impulsivity
Time frame: Baseline and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oleoylethanolamide in people with Alcohol Use Disorder (AUD), run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peripheral IL-6 Concentration (time frame: Baseline and week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.