What side effects are associated with this type of intervention?

Common treatments for alcoholism include medications like disulfiram, naltrexone, and acamprosate. Disulfiram can cause side effects such as drowsiness, headache, and a metallic taste, and it can lead to severe reactions if alcohol is consumed. Naltrexone may cause nausea, headache, dizziness, and fatigue. Acamprosate's side effects include diarrhea, anxiety, and insomnia. Probenecid, which is being studied for alcohol use disorder, is known to inhibit renal excretion of uric acid and can cause side effects like gastrointestinal upset, rash, and kidney stones. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

FDA-approved drugs for the treatment of alcoholism include disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, naltrexone blocks the euphoric effects of alcohol, and acamprosate helps to restore the chemical balance in the brain. Unlike Probenecid, which inhibits renal excretion of uric acid, these medications primarily target the neurological pathways associated with alcohol dependence.

What other types of research exist?

Promising novel alternatives to Probenecid for treating alcoholism include medications targeting different mechanisms such as naltrexone (an opioid receptor antagonist), acamprosate (modulates glutamate neurotransmission), and disulfiram (inhibits acetaldehyde dehydrogenase). Additionally, emerging treatments like baclofen (a GABA-B receptor agonist) and gabapentin (an anticonvulsant) are being investigated for their efficacy in alcohol use disorder.

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Probenecid for Alcohol Use Disorder (PROB Trial)

Phase 1

Waitlist Available

Led By Carolina L Haass-Koffler, PHARMD

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from day 3 to day 10 of the trial

Summary

This trial tests an oral dose of 2g probenecid in people. Probenecid may change how the body handles alcohol. The study aims to see if this medication affects alcohol's impact on participants.

Who is the study for?

This trial is for adults aged 21-70 who drink more than the moderate amount weekly and are in good health. They must not be pregnant, breastfeeding, have kidney issues, or take certain medications like aspirin or methotrexate. Participants should not have other substance disorders (except nicotine) and no recent history of suicide attempts.

What is being tested?

The study tests Probenecid's effects on alcohol use disorder by comparing it with a placebo. Each participant will receive both treatments at different times in a controlled environment to see which one works better.

What are the potential side effects?

While specific side effects aren't listed here, probenecid may commonly cause allergic reactions in those sensitive to sulfa drugs, and interactions with various medications could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from day 3 to day 10 of the trial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from day 3 to day 10 of the trial

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from day 3 to day 10 of the trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stimulant effects of alcohol when co-administered with drug or matching placebo

Secondary study objectives

Alcohol craving

Sedative effects of alcohol when co-administered with drug or matching placebo

Side effects data

From 2020 Phase 4 trial • 8 Patients • NCT03965351

13%

Migraine

13%

Sore Throat

13%

Nausea

13%

Rhinovirus

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Probenecid

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ProbenecidExperimental Treatment1 Intervention

2g probenecid, one pill by mouth once, for one day

Group II: matching placeboPlacebo Group1 Intervention

Placebo, one pill by mouth once, for one day

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probenecid

2018

Completed Phase 4

~720

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcoholism include medications like disulfiram, naltrexone, and acamprosate. Disulfiram works by inhibiting the enzyme acetaldehyde dehydrogenase, causing unpleasant effects when alcohol is consumed, thus deterring drinking. Naltrexone is an opioid receptor antagonist that reduces the rewarding effects of alcohol, helping to decrease cravings and relapse rates. Acamprosate modulates glutamatergic neurotransmission, stabilizing the chemical balance in the brain disrupted by chronic alcohol use. These mechanisms are crucial for alcoholism patients as they address different aspects of addiction, from reducing the desire to drink to minimizing withdrawal symptoms, thereby supporting long-term recovery. Probenecid, while primarily used to inhibit renal excretion of uric acid, is being studied for its potential effects on other substances, which could offer new avenues for treating alcoholism by altering substance metabolism or excretion.

Chronic ethanol administration decreases 5-HT and increases 5-HIAA concentration in rat brain.