Probenecid as Medication for Alcohol Use Disorder

Overview

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 Title of Study: “Probenecid as Pharmacotherapy for Alcohol Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2, 2022

Detailed 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.

Interventions

  • Drug: Probenecid
    • safety
  • Drug: Matching placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Probenecid
    • 2g probenecid, one pill by mouth once, for one day
  • Placebo Comparator: matching placebo
    • Placebo, one pill by mouth once, for one day

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brown University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carolina Haass-Koffler, Assistant Professor – Brown University
  • Overall Official(s)
    • Carolina L Haass-Koffler, PHARMD, Principal Investigator, Brown University
  • Overall Contact(s)
    • Zoe Brown, BA, 401-863-6646, alcohol-stress-study@brown.edu

Citations Reporting on Results

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.

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