Testing diclofenac for treating alcohol use disorder
Proof of Concept: Diclofenac as a KMO Inhibitor in Individuals With Alcohol Use Disorder
This study is testing if a medication called diclofenac can help people with Alcohol Use Disorder by looking at how it affects certain chemicals in their blood.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Catonsville, Maryland) |
| Trial ID | NCT06029296 on ClinicalTrials.gov |
What this trial studies
This proof of concept laboratory study aims to evaluate the effects of diclofenac on individuals with Alcohol Use Disorder (AUD). Participants will undergo two sessions where they will receive either a single dose of diclofenac (100 mg) or a matched placebo in a randomized, double-blind manner. The primary goal is to determine if diclofenac increases levels of kynurenic acid in the bloodstream, indicating its potential role as a kynurenine 3-monooxygenase inhibitor. This study will provide insights into the pharmacological properties of diclofenac in the context of AUD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 who meet the DSM-5 criteria for Alcohol Use Disorder of any severity.
Not a fit: Patients with serious psychiatric disorders, significant withdrawal symptoms, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals struggling with alcohol use disorder.
How similar studies have performed: While this approach is novel in the context of AUD, similar pharmacological interventions have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 21-65 * Meet DSM-5 diagnostic criteria for AUD of any severity (Mild, Moderate, or Severe) Exclusion Criteria: * 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
Where this trial is running
Catonsville, Maryland
- Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) — Catonsville, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Roche, PhD — University of Maryland, Baltimore
- Study coordinator: Brian Brandler, MA
- Email: bbrandler@som.umaryland.edu
- Phone: 410-402-6425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.