Probenecid as Medication for Alcohol Use Disorder (PROB)

NCT04218357 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 1908002524
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The design is a randomized, within-subject, crossover, double-blind, placebo-controlled human alcohol laboratory study with one oral dose of 2g probenecid or placebo administered in two laboratory sessions.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo

  The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES). The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome). The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.

  Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

Secondary Outcomes (2)

• Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo

  Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

• Alcohol Craving

  Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

Study Arms (2)

Probenecid

EXPERIMENTAL

2g probenecid, one pill by mouth once, for one day

Drug: Probenecid or placebo single administration

matching placebo

PLACEBO COMPARATOR

Placebo, one pill by mouth once, for one day

Drug: Probenecid or placebo single administration

Interventions

Probenecid or placebo single administration DRUG

study drug administration with alcohol in the laboratory

Also known as: Probalan

Probenecid; matching placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 21-70 (inclusive) years; women \>7 drinks/week; men \>14 drinks/week;
• meet any DSM-5 criteria score for AUD;
• 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 have a positive urine screen for pregnancy
• CrCl \< 60mL/min
• Taking aspirin (salicylates may reduce effect of probenecid)
• Taking penicillin
• Taking methotrexate (may increase concentration)
• Taking other medications that may interact with probenecid
• History of suicide attempts in the last three years
• Current diagnosis of another substance disorder(s) other than nicotine, as assessed by self-reports and urine toxicology screen at baseline
• History of hypersensitivity to sulfa drugs

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 20923, United States

Location

Related Publications (2)

• Tunstall BJ, Lorrai I, McConnell SA, Gazo KL, Zallar LJ, de Guglielmo G, Hoang I, Haass-Koffler CL, Repunte-Canonigo V, Koob GF, Vendruscolo LF, Sanna PP. Probenecid Reduces Alcohol Drinking in Rodents. Is Pannexin1 a Novel Therapeutic Target for Alcohol Use Disorder? Alcohol Alcohol. 2019 Jan 9;54(5):497-502. doi: 10.1093/alcalc/agz054.

  PMID: 31535696 RESULT

• 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 RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

Probenecid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Carolina Haass-Koffler, PharmD, PhD
• Organization: Brown University

carolina_haass-koffler@brown.edu

4155191385

Study Officials

• Carolina L Haass-Koffler, PHARMD, PHD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 6, 2020
• Study Start: December 2, 2020
• Primary Completion: May 16, 2023
• Study Completion: May 20, 2023
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)