Probenecid as Medication for Alcohol Use Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Probenecid as Pharmacotherapy for Alcohol Use Disorder

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Probenecid
* Drug: Matching placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probenecid<br>2g probenecid, one pill by mouth once, for one day | Drug: Probenecid<br>* safety<br>* Other names: Probalan;|
| Placebo Comparator: matching placebo<br>Placebo, one pill by mouth once, for one day | Drug: Matching placebo<br>* Placebo<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulant effects of alcohol when co-administered with drug or matching placebo | assessed using the change in the Biphasic Alcohol Effects Scale (BAES), scale 0-10 (direct and reverse score) | Change from Day 3 to day 10 of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedative effects of alcohol when co-administered with drug or matching placebo | assessed using change in the Biphasic Alcohol Effects Scale (BAES), scale 0-10 (direct and reverse score) | Change from Day 3 to day 10 of the trial | 
| Alcohol craving | assessed using change in the alcohol urge questionnaire (AUQ), scale 0-7 (7 worse outcome) | Change from Day 3 to day 10 of the trial |