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New treatment option for Alcohol Use Disorder (AUD)
Official title Probenecid Administration for Alcohol Craving and Consumption
ClinicalTrials.gov ID: NCT07118618
What this study is testing
What is Probenecid Oral Tablet?
Probenecid Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for alcohol use disorder (aud).
Also referred to as Probalan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study proposes a 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo in individuals with AUD to test if reduces craving and alcohol consumption.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, ≥18 years.
- women \>7 drinks/week; men \>14 drinks/week.
- meet moderate to severe AUD score for DSM-5 criteria.
- Breath Alcohol Content (BrAC)=0.00 at each visit.
- in good health as confirmed by medical history, physical examination and lab tests.
You likely can't join if
- Women who are breastfeeding or positive urine test for pregnancy.
- clinically significant medical abnormalities: unstable hypertension, clinically significant abnormal EKG, bilirubin \>150% of the upper normal limit...
- meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
- medications that reduce alcohol consumption (naltrexone, disulfiram).
- use aspirin (salicylates may reduce effect of probenecid), penicillin, methotrexate (may increase concentration).
- history of suicide attempts in the last three years.
See the full eligibility criteria
- Male or female, ≥18 years.
- women \>7 drinks/week; men \>14 drinks/week.
- meet moderate to severe AUD score for DSM-5 criteria.
- Breath Alcohol Content (BrAC)=0.00 at each visit.
- in good health as confirmed by medical history, physical examination and lab tests.
- willing to adhere to the study procedures.
- understand informed consent and questionnaires in English at an 8th grade level.
- Women who are breastfeeding or positive urine test for pregnancy.
- clinically significant medical abnormalities: unstable hypertension, clinically significant abnormal EKG, bilirubin \>150% of the upper normal limit, ALT/AST \>300% the UNL, creatinine clearance ≤60 dl/min
- meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
- medications that reduce alcohol consumption (naltrexone, disulfiram).
- use aspirin (salicylates may reduce effect of probenecid), penicillin, methotrexate (may increase concentration).
- history of suicide attempts in the last three years.
- current diagnosis of a moderate or severe cannabis use disorder as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
- current diagnosis of another substance disorder at any severity, other than nicotine, as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
- current use of medications that may interact with probenecid.
- history of hypersensitivity to sulfa drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.