Status:
ACTIVE_NOT_RECRUITING
Diclofenac as a KMO Inhibitor
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-65 years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Ages 21-65
- Meet DSM-5 diagnostic criteria for AUD of any severity (Mild, Moderate, or Severe)
Exclusion
- Lifetime DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders and bipolar and related disorders
- Positive urine toxicology screen for the following substances: cocaine, opiates, amphetamines, methamphetamine, phencyclidine, barbiturates, benzodiazepine, methadone, and tricyclic antidepressants
- Self-reported daily use of opioids (including prescribed)
- Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
- If female: pregnant, nursing, or with reproductive potential who refuses to use reliable methods of birth control throughout the study
- Any autoimmune disorder, inflammatory disorder, or medical condition that may interfere with safe study participation and/or study aims (e.g., any cardiac, renal, or liver disease, uncontrolled hypertension, or diabetes)
- Attempted suicide in the past 3 years and/or serious suicidal intention or plan within the past year
- 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
- Previously known hypersensitivity, including gastroenteritis, asthma, and allergic-type reactions, to any NSAID and/or aspirin
- Current daily use of any NSAID or regular pattern of near daily use within the past three months, regular use of a prebiotic or probiotic supplement and/or any antibiotic, prebiotic, or probiotic use within the last month
- Any lifetime history of ulcer disease, gastritis, gastroenteritis, or gastrointestinal bleeding
- Current or recent (within 3 months) participation in a clinical trial involving medication administration
- Currently in treatment, a history of treatment within the 30 days before enrollment, or currently seeking immediate treatment for AUD
- Current (last 12 months) DSM-5 diagnosis of SUD for any psychoactive substances other than alcohol and nicotine
- Currently prescribed a psychotropic medication for the treatment of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders
- AST and ALT \> four times the upper limit of the normal range, or albumin, GFR, BUN, or creatinine 15% \> the upper limit of the normal range
- Suffered a mild or moderate traumatic brain injury (TBI) within the last 12 months, a severe TBI at any point in their life, or a moderate TBI before the age of 12
- Has below a 6th grade reading level
- Within the last 3 months, tested positive for COVID-19 (i.e. the SARS-CoV-2 virus) and experienced common related symptoms
- Any other circumstances that, in the opinion of the investigators, compromises participant safety, ability of the investigators to conduct the study as designed, and/or study integrity
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06029296
Start Date
July 31 2024
End Date
January 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
Catonsville, Maryland, United States, 21228