Recruiting
Phase 2

Probenecid

Sponsor:

Brown University

Code:

NCT07118618

Conditions

Alcohol Use Disorder (AUD)

Alcohol Consumption

Craving

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Probenecid Oral Tablet

Placebo Oral Tablet

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder (AUD)

Alcohol Consumption

Craving

Study ID

NCT07118618

Start date

Mar 14, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Study drug

Probenecid 2gr oral

placebo comparator: Placebo

Placebo inactive

Interventions

Probenecid Oral Tablet

2gr daily

Placebo Oral Tablet

Inactive compound

Primary outcome measure

  • Acute Alcohol Craving [ Time Frame: 5- week ]

Central Contacts and Locations

Central contacts

Brian Gully, MA

401-863-6646brian_gully@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Brian Gully, MA

alcohol-stress-study@brown.edu

More Information

Sponsor

Brown University

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • AUD
  • Probenecid
  • Craving
  • Alcohol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2026-03-17.