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KMO Inhibitor

Diclofenac for Alcohol Use Disorder (DKMOI Trial)

Phase < 1
Recruiting
Led By Daniel Roche, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 21-65
Be older than 18 years old
Must not have
Currently on prescription medication that contraindicates use of diclofenac, including but not necessarily limited to: oral corticosteroids, anticoagulants, lithium, warfarin, aspirin (daily use), methotrexate, cyclosporine, ACE-inhibitors, and diuretics like furosemide and thiazides
Currently prescribed a psychotropic medication for the treatment of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-, 60-, 120-, 180-, and 240-minutes after pill administration

Summary

This trial tests if diclofenac (100mg) can help people with AUD by increasing their kynurenic acid levels. The effects are tested in 2 sessions with a placebo.

Who is the study for?
This trial is for individuals aged 21-65 with Alcohol Use Disorder (AUD) of any severity, who are not pregnant or nursing, and do not use certain drugs. Participants must not be on medications that interact with diclofenac, seeking AUD treatment, or have had recent substance abuse other than alcohol and nicotine.
What is being tested?
The study tests if a single dose of diclofenac (100 mg) can increase kynurenic acid levels in the blood compared to a placebo. This could show whether diclofenac inhibits an enzyme related to AUD. The process is randomized and double-blind.
What are the potential side effects?
Diclofenac may cause side effects like digestive issues (nausea, vomiting), headaches, dizziness, skin reactions, liver function changes, and increased risk of heart attack or stroke. It's important to monitor for these during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking medication that can't be mixed with diclofenac.
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I am taking medication for schizophrenia, bipolar disorder, or similar conditions.
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I have had a mild or moderate brain injury in the last year, or a severe one at any time, or a moderate one before age 12.
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I have had ulcers or stomach bleeding in the past.
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I am not pregnant, nursing, or willing to use birth control if I can have children.
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I tested positive for COVID-19 and had symptoms in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-, 60-, 120-, 180-, and 240-minutes after pill administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-, 60-, 120-, 180-, and 240-minutes after pill administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Kynurenic Acid

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DiclofenacActive Control1 Intervention
Participants will take a single 100mg dose of diclofenac.
Group II: PlaceboPlacebo Group1 Intervention
Participants will take a single dose of placebo.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,480 Total Patients Enrolled
8 Trials studying Alcoholism
607 Patients Enrolled for Alcoholism
Daniel Roche, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
3 Previous Clinical Trials
83 Total Patients Enrolled
3 Trials studying Alcoholism
83 Patients Enrolled for Alcoholism
~0 spots leftby Dec 2024
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