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Completed

NCT Number: NCT04218357

Probenecid as Medication for Alcohol Use Disorder (PROB)

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brown University

Providence, Rhode Island, 20923, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probenecid or placebo single administration

Drug

study drug administration with alcohol in the laboratory

Other names: Probalan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

Probenecid as Pharmacotherapy for Alcohol Use Disorder

Acronym: PROB

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2020
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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