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NCT Number: NCT07118618

Probenecid Administration for Alcohol Craving and Consumption

This study proposes a 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo in individuals with AUD to test if reduces craving and alcohol consumption.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Brian Gully, MA

CONTACT

[email protected]

About this study

There are three aims in this study that test the hypothesis that probenecid compared to placebo, decreases:

  • Aim 1 (laboratory phase): acute alcohol craving.
  • Aim 2 (naturalistic phase): alcohol craving.
  • Aim 3 (naturalistic phase): alcohol consumption

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Male or female, ≥18 years.
  • women >7 drinks/week; men >14 drinks/week.
  • meet moderate to severe AUD score for DSM-5 criteria.
  • 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 positive urine test for pregnancy.
  • clinically significant medical abnormalities: unstable hypertension, clinically significant abnormal EKG, bilirubin >150% of the upper normal limit, ALT/AST >300% the UNL, creatinine clearance ≤60 dl/min
  • meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
  • medications that reduce alcohol consumption (naltrexone, disulfiram).
  • use aspirin (salicylates may reduce effect of probenecid), penicillin, methotrexate (may increase concentration).
  • history of suicide attempts in the last three years.
  • current diagnosis of a moderate or severe cannabis use disorder as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
  • current diagnosis of another substance disorder at any severity, other than nicotine, as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
  • current use of medications that may interact with probenecid.
  • history of hypersensitivity to sulfa drugs.

Treatment and study plan

Probenecid Oral Tablet

Drug

2gr daily

Other names: Probalan

Placebo oral tablet

Drug

Inactive compound

Other names: Matching Inactive Oral Tablet

Primary outcomes

  1. Acute Alcohol Craving

    Time frame: 5- week

    Acute alcohol craving during an alcohol cue-reactivity procedure assessed using change in the alcohol urge questionnaire (AUQ). 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)

Secondary outcomes

  1. Alcohol craving

    Time frame: 12-week

    Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS). The OCDS is a 14-item questionnaire, each rated on a scale from 0 to 4 that measures individuals' alcohol use and their attempts to control their drinking. Range Min score 0; max score. OCDS can also divided into two subscales: Obsessive subscale (items 1-6): max score = 24; Compulsive subscale (items 7-14): max score = 32. Higher scores reflect greater alcohol craving (worse outcome). Each item contributes equally to the total, and higher scores reflect greater obsessive and compulsive thoughts and behaviors related to alcohol use.

Other outcomes

  1. Alcohol consumption

    Time frame: 12-week

    Number of standard drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Gully, MA

CONTACT

[email protected]

401-863-6646

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

Probenecid, Pannexin 1 Channels for Alcohol Use Disorder

Acronym: PROB2

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 12, 2025
Registry last updated
Mar 17, 2026

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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