Is NCT06636227 recruiting in Catonsville, MD?

Yes, NCT06636227 is currently recruiting participants at its Catonsville, MD location. This alcohol use disorder (aud) clinical trial is actively enrolling qualified participants.

How do I join the alcohol use disorder (aud) clinical trial in Catonsville?

To join this clinical trial in Catonsville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Catonsville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Alcohol Use Disorder (AUD) Clinical Trial in Catonsville, MD

About This Alcohol Use Disorder (AUD) Study in Catonsville

The development of efficacious medications for AUD remains a high research priority with current emphases on identifying novel molecular targets and efficiently screening new compounds. Pharmacological modulation of the kynurenine pathway (KP) represents a promising novel target for AUD. The KP is a complex enzymatic cascade with each step producing biologically active metabolites that are critically involved in diverse physiological and pathological processes. Chronic alcohol exposure produces dysregulation of the KP, particularly as evidenced by decreased levels of the neuroprotective metabolite kynurenic acid (KYNA) and increased levels of the neurotoxic metabolite quinolinic acid (QUIN). This metabolic shift is associated with various alcohol-related pathologies in animals and humans. Thus, a medication that targets the KP to restore KYNA and attenuate QUIN levels may be an effective treatment for AUD. The enzyme kynurenine 3- monooxygenase (KMO) is a major gatekeeper of the KP and resultant KYNA levels. KMO inhibition shifts the KP towards KYNA production in brain and away from QUIN production. Critically, KMO inhibition in rodents, through its increase in brain KYNA levels, decreases alcohol self-administration, preference, cue-reactivity, and relapse behaviors. However, KMO-inhibitors have not been tested in humans because of presumed lack of availability. Diclofenac is an FDA-approved Non-Steroidal Anti-Inflammatory Drug that was recently discovered to inhibit KMO activity. Consistent with KMO inhibition, diclofenac increases KYNA levels in the brain and periphery of rodents. However, it remains unknown whether diclofenac increases KYNA levels and affects alcohol-related behaviors in humans at approved, safe dosages. Investigators propose to conduct a human laboratory pilot study to test whether diclofenac can increase KYNA in individuals with AUD, and if so, which of 3 doses (50, 75, or 100 mg) most effectively increases KYNA. Individuals with AUD (n = 24) will complete four sessions where they receive diclofenac (50, 75, or 100 mg) or placebo. Investigators will examine increases in KYA levels and will also assess QUIN levels, alcohol craving, and negative mood.

Sponsor: University of Maryland, Baltimore

Who Can Participate

Inclusion Criteria

Meet DSM-5 diagnostic criteria for current AUD of any severity (Mild, Moderate, or Severe)

In the 30-day period before enrollment, consume \> 14 and \> 7 standard drinks per week for men and women, respectively

In the 30-day period before enrollment, engage in heavy drinking (5 or more drinks for men, 4 or more drinks for women) ≥ 5 times per month

Exclusion Criteria

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, nicotine, and cannabis (cannabis use disorder, mild severity allowed; moderate and severe excluded)

Currently prescribed a psychotropic medication for the treatment of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders

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 current daily use of opioids (including prescribed)

If female: pregnant, nursing, or with reproductive potential who refuses to use reliable methods of birth control throughout the study

Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised

Any autoimmune disorder, inflammatory disorder, hypercoagulable state, cardiovascular disease or other medical condition (e.g., any cardiac, renal, or liver disease, uncontrolled hypertension, or diabetes) that may interfere with safe study participation and/or study aims. Specific examples of exclusionary medical conditions include but are not limited to:

Any lifetime history of 1) serious GI conditions, including ulcer disease, gastrointestinal bleeding, and clinically significant gastritis, or, 2) serious cardiovascular conditions, including heart failure, myocardial infarction, stroke, pulmonary embolism, blood clots, deep vein thrombosis, or clotting disorder, 3) liver disease or impaired liver function, and 4) renal disease or insufficiency

Current uncontrolled hypertension

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

Clinically significant ECG findings, including clinically significant arrhythmia, atrioventricular block, prolonged QTc interval, or enlarged or hypertrophic heart

Serious brain conditions, including epilepsy, dementia and neurodegenerative diseases, traumatic brain injury (TBI), etc. TBI exclusionary criteria include: suffered a mild or moderate TBI within the last 12 months, a severe TBI at any point in their life, or a moderate TBI before the age of 12

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, diuretics like furosemide and thiazides, and any medication that significantly influences CYP2C9 enzyme activity (e.g., rifampin, voriconazole).

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 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

Current or recent (within 3 months) participation in a clinical trial involving medication administration

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Catonsville?

Yes, this clinical trial (NCT06636227) has an active research site in Catonsville, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alcohol Use Disorder (AUD) Treatment Options in Catonsville, MD

If you're searching for alcohol use disorder (aud) treatment options in Catonsville, MD, this clinical trial (NCT06636227) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Catonsville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced alcohol use disorder (aud) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alcohol use disorder (aud) clinical trials near you to find additional studies recruiting in your area.

Alcohol Use Disorder (AUD) Clinical Trial in Catonsville, MD

Expert Care in Catonsville

IRB Approved

No-Cost Care

Apply for This Catonsville Location

Why Participate?

Simple Process