ACTIVE_NOT_RECRUITING

Diclofenac as a KMO Inhibitor

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Conditions

Alcohol Use Disorderdiclofenac

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-31
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06029296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 21-65
  2. * Meet DSM-5 diagnostic criteria for AUD of any severity (Mild, Moderate, or Severe)
  1. * Lifetime DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders and bipolar and related disorders
  2. * Positive urine toxicology screen for the following substances: cocaine, opiates, amphetamines, methamphetamine, phencyclidine, barbiturates, benzodiazepine, methadone, and tricyclic antidepressants
  3. * Self-reported daily use of opioids (including prescribed)
  4. * Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
  5. * If female: pregnant, nursing, or with reproductive potential who refuses to use reliable methods of birth control throughout the study
  6. * 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)
  7. * Attempted suicide in the past 3 years and/or serious suicidal intention or plan within the past year
  8. * 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
  9. * Previously known hypersensitivity, including gastroenteritis, asthma, and allergic-type reactions, to any NSAID and/or aspirin
  10. * 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
  11. * Any lifetime history of ulcer disease, gastritis, gastroenteritis, or gastrointestinal bleeding
  12. * Current or recent (within 3 months) participation in a clinical trial involving medication administration
  13. * Currently in treatment, a history of treatment within the 30 days before enrollment, or currently seeking immediate treatment for AUD
  14. * Current (last 12 months) DSM-5 diagnosis of SUD for any psychoactive substances other than alcohol and nicotine
  15. * Currently prescribed a psychotropic medication for the treatment of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders
  16. * 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
  17. * 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
  18. * Has below a 6th grade reading level
  19. * Within the last 3 months, tested positive for COVID-19 (i.e. the SARS-CoV-2 virus) and experienced common related symptoms
  20. * 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

Contacts and Locations

Principal Investigator

Daniel Roche, PhD
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore

Study Locations (Sites)

Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
Catonsville, Maryland, 21228
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Daniel Roche, PhD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-07-31
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • diclofenac

Additional Relevant MeSH Terms

  • Alcohol Use Disorder