Probenecid as Medication for Alcohol Use Disorder (PROB) (PROB)

February 6, 2025 updated by: Carolina L Haass-Koffler, Brown University

Probenecid as Pharmacotherapy for Alcohol Use Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 20923
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probenecid
2g probenecid, one pill by mouth once, for one day
Drug: Probenecid or placebo single administration
study drug administration with alcohol in the laboratory
Other Names:
  • Probalan
Placebo Comparator: matching placebo
Placebo, one pill by mouth once, for one day
Drug: Probenecid or placebo single administration
study drug administration with alcohol in the laboratory
Other Names:
  • Probalan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo
Time Frame: 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 (high, worse outcome).

The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. & Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo
Time Frame: 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, worse outcome).

The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. & Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
Alcohol Craving
Time Frame: 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 7 are reverse scored. A total score is computed by averaging the item scores. Minimum score is 7, maximum score is 48. Higher scores reflect greater alcohol craving (worse outcome).
Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Investigators

  • Principal Investigator: Carolina L Haass-Koffler, PHARMD, PHD, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Actual)

May 16, 2023

Study Completion (Actual)

May 20, 2023

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1908002524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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