Probenecid Administration for Alcohol Craving and Consumption

NCT ID: NCT07118618

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2030-12-31

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.

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

Conditions

Alcohol Use Disorder (AUD); Alcohol Consumption; Craving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Study drug

Probenecid 2gr oral

Group Type: EXPERIMENTAL

Probenecid Oral Tablet

Intervention Type: DRUG

2gr daily

Placebo

Placebo inactive

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Inactive compound

Interventions

Probenecid Oral Tablet

2gr daily

Intervention Type: DRUG

Placebo Oral Tablet

Inactive compound

Intervention Type: DRUG

Other Intervention Names

Probalan; Matching Inactive Oral Tablet

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Carolina L Haass-Koffler

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolina Haass-Koffler, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown Univiversity

Central Contacts

Brian Gully, MA

Role: CONTACT

brian_gully@brown.edu

401-863-6646

References

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.

Reference Type: BACKGROUND

PMID: 39472130 (View on PubMed)

Other Identifiers

STUDY00000881

Identifier Type: -

Identifier Source: org_study_id