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NCT06636227 · ClinicalTrials.gov registry record · Phase 1
Diclofenac Dose Response Study
A Phase 1 study of Alcohol Use Disorder (AUD) and Alcohol-Related Disorders, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06636227 is a Phase 1 study of Alcohol Use Disorder (AUD) and Alcohol-Related Disorders that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 24 participants, below the 1,823-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06636227, a Phase 1 study of Alcohol Use Disorder (AUD) and Alcohol-Related Disorders, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The development of efficacious medications for AUD remains a high research priority with current emphases on identifying novel molecular targets and efficiently screening new compounds. Pharmacological modulation of the kynurenine pathway (KP) represents a promising novel target for AUD. The KP is a complex enzymatic cascade with each step producing biologically active metabolites that are critically involved in diverse physiological and pathological processes. Chronic alcohol exposure produces dysregulation of the KP, particularly as evidenced by decreased levels of the neuroprotective metabolite kynurenic acid (KYNA) and increased levels of the neurotoxic metabolite quinolinic acid (QUIN). This metabolic shift is associated with various alcohol-related pathologies in animals and humans. Thus, a medication that targets the KP to restore KYNA and attenuate QUIN levels may be an effective treatment for AUD. The enzyme kynurenine 3- monooxygenase (KMO) is a major gatekeeper of the KP and resultant KYNA levels. KMO inhibition shifts the KP towards KYNA production in brain and away from QUIN production. Critically, KMO inhibition in rodents, through its increase in brain KYNA levels, decreases alcohol self-administration, preference, cue-reactivity, and relapse behaviors. However, KMO-inhibitors have not been tested in humans because of presumed lack of availability. Diclofenac is an FDA-approved Non-Steroidal Anti-Inflammatory Drug that was recently discovered to inhibit KMO activity. Consistent with KMO inhibition, diclofenac increases KYNA levels in the brain and periphery of rodents. However, it remains unknown whether diclofenac increases KYNA levels and affects alcohol-related behaviors in humans at approved, safe dosages. Investigators propose to conduct a human laboratory pilot study to test whether diclofenac can increase KYNA in individuals with AUD, and if so, which of 3 doses (50, 75, or 100 mg) most effectively increases KYNA. Individuals with AUD (n = 24)
Conditions Studied
Interventions
- DRUG Placebo control
- DRUG Diclofenac 100mg
- DRUG Diclofenac 75mg
- DRUG Diclofenac 50mg
Study Locations (1)
Maryland
- Maryland Psychiatric Research Center - Catonsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06636227
The ClinicalTrials.gov registry entry for NCT06636227 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,823-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (99% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alcohol Use Disorder (AUD) appearing as the primary indexed condition, and to 4 interventions - of which Placebo control is the first listed.
NCT06636227 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06636227 about?
NCT06636227 is a clinical study titled "Diclofenac Dose Response Study". The development of efficacious medications for AUD remains a high research priority with current emphases on identifying novel molecular targets and efficiently screening new compounds. Pharmacological modulation of the kynurenine pathway (KP) represents a promising novel target for AUD. The KP is a...
What is the current status of trial NCT06636227?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-12-01. Estimated completion is 2026-08-31.
What conditions does trial NCT06636227 study?
This clinical trial studies the following conditions: Alcohol Use Disorder (AUD), Alcohol-Related Disorders.
What interventions are being tested in trial NCT06636227?
The interventions under investigation include: Placebo control (DRUG), Diclofenac 100mg (DRUG), Diclofenac 75mg (DRUG), Diclofenac 50mg (DRUG).
Who is sponsoring clinical trial NCT06636227?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06636227 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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