Phase 1 N=35 Randomized Quadruple-blind Other

Probenecid as Medication for Alcohol Use Disorder (PROB)

Alcohol Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04218357 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo — 28.23; 25.26; 20.57; 19.56 scores on scale

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Probenecid or placebo single administration (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Brown University
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo	28.23; 25.26; 20.57; 19.56	—
SECONDARY Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo	16.02; 16.79; 16.26; 16.50	—
SECONDARY Alcohol Craving	23.09; 17.24; 19.63; 18.38	0.05

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04218357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.