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Probenecid for Alcohol Use Disorder (PROB Trial)

Phase 1
Recruiting
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
Meet any DSM-5 criteria score for AUD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from day 3 to day 10 of the trial
Awards & highlights

PROB Trial Summary

This trial tests the effects of probenecid, given as a single 2g dose, on alcohol intoxication in humans. The trial is double-blind, meaning that neither the participants nor the staff administering the drug will know who is receiving probenecid or placebo. The study is also placebo-controlled, meaning that a group of participants will receive a placebo (a 'sugar pill') instead of probenecid.

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.Check my eligibility
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.See study design
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.

PROB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with Alcohol Use Disorder (AUD) based on specific criteria outlined in the DSM-5.

PROB Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stimulant effects of alcohol when co-administered with drug or matching placebo
Secondary outcome measures
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%
0%
Study treatment Arm
Placebo
Probenecid

PROB 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
~690

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
452 Previous Clinical Trials
562,162 Total Patients Enrolled
28 Trials studying Alcoholism
5,081 Patients Enrolled for Alcoholism
Carolina L Haass-Koffler, PHARMDPrincipal InvestigatorBrown University
1 Previous Clinical Trials
184 Total Patients Enrolled
1 Trials studying Alcoholism
184 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential adverse effects can be associated with Probenecid usage?

"Probenecid's safety was rated a 1 due to the limited research and data associated with Phase 1 trials."

Answered by AI

How many participants are being monitored for this research endeavor?

"Affirmative. Clinicaltrials.gov indicates that this scientific research, which was initially posted on December 2nd 2020, is actively searching for volunteers. Approximately 34 participants must be solicited from 1 clinical setting."

Answered by AI

Is this investigation currently enrolling participants?

"According to clinicaltrials.gov, recruitment for this trial is actively underway having been first posted on December 2nd 2020 and most recently edited on July 18th 2022."

Answered by AI

Who is able to qualify to join this clinical trial?

"To meet the criteria for this study, individuals should have a history of alcohol usage and be between 21 to 70 years old. Accordingly, 34 applicants are being recruited."

Answered by AI

In what circumstances is Probenecid usually prescribed?

"Probenecid can be employed to manage gouty arthritis, arthritis, gouty and hyperuricemia."

Answered by AI

Are there prior investigations that have examined Probenecid?

"Currently, 3 Probenecid trials are in progress with 2 of them at the final Phase 3 stage. While many occur near Providence, Rhode island, 4 locations overall are hosting these clinical studies."

Answered by AI

Is the elderly cohort being included in this exploration of treatment options?

"To qualify for this particular trial, individuals must be between 21 and 70 years old. There are 33 trials geared towards people younger than 18, and 252 studies available to those aged 65 or older."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Brown University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~8 spots leftby Mar 2025