NCT06029296

Diclofenac as a KMO Inhibitor

Proof of Concept: Diclofenac as a KMO Inhibitor in Individuals With Alcohol Use Disorder

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This mechanistic, proof of concept laboratory study will test the pharmacological properties of diclofenac in individuals with AUD. Participants will complete two sessions in which they will receive a single dose of diclofenac (100 mg) or matched placebo in a randomized and double blind fashion. The primary aim is to assess whether this dose of diclofenac, vs. placebo, increases circulating levels of kynurenic acid. This finding would provide evidence that diclofenac (100 mg) inhibits the kynurenine 3-monooxygenase enzyme.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Diclofenac	100 mg
DRUG	Placebo	Sugar pill

Timeline

• Start date: 2024-07-31
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-09-08
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study