Probenecid as Medication for Alcohol Use Disorder (PROB)

Brown University

Status and phase: Completed; Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: Probenecid or placebo single administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04218357

1908002524

Details and patient eligibility

About

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.

Full description

There will be a total of four study visits. Visit 1 is the screening for eligibility (medical and physical examination). On Visits 2 and 3, participants will undergo an alcohol laboratory session with a one week washout period before administering the alternate therapy. The study will conclude at Visit 4.

Enrollment: 35 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Probenecid

Experimental group

Description:

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

Treatment:

Drug: Probenecid or placebo single administration

matching placebo

Placebo Comparator group

Description:

Placebo, one pill by mouth once, for one day

Treatment:

Drug: Probenecid or placebo single administration