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NCT04218357: PROB

Probenecid as Medication for Alcohol Use Disorder (PROB)

Completed Phase 1 Results posted Last updated 27 February 2025
What this trial tests

Phase 1 trial testing Probenecid or placebo single administration in Alcohol Use Disorder in 35 participants. Completed in 20 May 2023.

Timeline
2 December 2020
Primary endpoint
16 May 2023
20 May 2023

Quick facts

Lead sponsorBrown University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposeother
Enrollment35
Start date2 December 2020
Primary completion16 May 2023
Estimated completion20 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brown University

Who can join

Adults 21 to 70, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo Primary · Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

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 (hi

Ascending alcohol BrAC
GroupValue95% CI
Matching Placebo28.23± 21.82
Probenecid25.26± 20.66
Descending alcohol BrAC
GroupValue95% CI
Matching Placebo20.57± 18.95
Probenecid19.56± 20.33
Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo Secondary · Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

The sedative 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 sedation 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,

Ascending limb of BrAC
GroupValue95% CI
Matching Placebo16.02± 14.21
Probenecid16.79± 15.17
Descending limb of BrAC
GroupValue95% CI
Matching Placebo16.26± 15.27
Probenecid16.50± 15.15
Alcohol Craving Secondary · Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

Alcohol craving is assessed using change in the alcohol urge questionnaire (AUQ). The Alcohol Urge Questionnaire (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

Ascending limb of BrAC
GroupValue95% CI
Matching Placebo23.09± 13.23
Probenecid17.24± 10.47
Descending limb of BrAC
GroupValue95% CI
Matching Placebo19.63± 12.04
Probenecid18.38± 12.29

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Promising immunomodulators for management of substance and alcohol use disorders.
    Acuña AM, Park C, Leyrer-Jackson JM, Olive MF. · · 2024 · cited 5× · PMID 38803314 · DOI 10.1080/14656566.2024.2360653
  2. Orphan peptide and G protein-coupled receptor signalling in alcohol use disorder.
    Anversa RG, Maddern XJ, Lawrence AJ, Walker LC. · · 2024 · cited 4× · PMID 38073127 · DOI 10.1111/bph.16301
  3. Probenecid as a pharmacotherapy for alcohol use disorder: A randomized placebo-controlled alcohol interaction trial.
    Hornbacher R, Gully BJ, Brown ZE, Brown JC, et al · · 2024 · cited 3× · PMID 39472130 · DOI 10.1111/acer.15470

Verify or expand the search:

Other recruiting trials for Alcohol Use Disorder

Currently open trials in the same condition.

Other Brown University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04218357.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing