Probenecid Administration for Alcohol Craving and Consumption

NCT07118618 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00000881
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 Consumption; Craving; Alcohol Use Disorder (AUD)

Keywords

AUD; Probenecid; Craving; Alcohol

Outcome Measures

Primary Outcomes (1)

• Acute Alcohol Craving

  Acute alcohol craving during an alcohol cue-reactivity procedure assessed using change in the alcohol urge questionnaire (AUQ). AUQ consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). Drinking refers to various types of alcohol, including beer, wine and liquor. The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Minimum score is 7, maximum score is 48. Higher scores reflect greater alcohol craving (worse outcome)

  5- week

Secondary Outcomes (1)

• Alcohol craving

  12-week

Other Outcomes (1)

• Alcohol consumption

  12-week

Study Arms (2)

Study drug

EXPERIMENTAL

Probenecid 2gr oral

Drug: Probenecid Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo inactive

Drug: Placebo Oral Tablet

Interventions

Probenecid Oral Tablet DRUG

2gr daily

Also known as: Probalan

Study drug

Placebo Oral Tablet DRUG

Inactive compound

Also known as: Matching Inactive Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• willing to adhere to the study procedures.
• understand informed consent and questionnaires in English at an 8th grade level.

You may not qualify 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, 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.

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

Probenecid

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Carolina Haass-Koffler, PharmD, PhD

  Brown Univiversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Gully, MA

CONTACT

401-863-6646; brian_gully@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 12, 2025
• Study Start: March 14, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)