Could a painkiller help treat alcoholism? scientists investigate
NCT ID NCT06029296
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a single dose of diclofenac, a common pain reliever, can change a specific brain chemical in people with alcohol use disorder. Twelve adults with mild to severe alcohol use disorder will receive either diclofenac or a placebo in a double-blind fashion. The goal is to see if diclofenac increases kynurenic acid levels, which may help understand how the brain works in addiction. This is an early-stage study focused on learning, not treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
Catonsville, Maryland, 21228, United States
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Other studies related to the condition(s) this trial covers.
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