Probenecid Administration for Alcohol Craving and Consumption
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probenecid Oral Tablet, Placebo Oral Tablet.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder (AUD), Alcohol Consumption, Craving. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Probenecid, Pannexin 1 Channels for Alcohol Use Disorder
Overview
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.
Detailed description
There are three aims in this study that test the hypothesis that probenecid compared to placebo, decreases:
* Aim 1 (laboratory phase): acute alcohol craving. * Aim 2 (naturalistic phase): alcohol craving. * Aim 3 (naturalistic phase): alcohol consumption
Interventions
- Drug Probenecid Oral Tablet
2gr daily - Drug Placebo Oral Tablet
Inactive compound
Primary outcome measures
- Acute Alcohol Craving [Time frame: 5- week]
Secondary outcome measures (1)
- Alcohol craving [Time frame: 12-week]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- • 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Brown University — Providence
Publications
- Hornbacher R, Gully BJ, Brown ZE, Brown JC, Magill M, Cioe PA, Swift RM, Sanna PP, Haass-Koffler CL. Probenecid as a pharmacotherapy for alcohol use disorder: A randomized placebo-controlled alcohol interaction trial. Alcohol Clin Exp Res (Hoboken). 2024 Dec;48(12):2391-2403. doi: 10.1111/acer.15470. Epub 2024 Oct 29. PMID 39472130
Identifiers
NCT: NCT07118618 · STUDY00000881