NCT07118618 · Brown University
Probenecid Administration for Alcohol Craving and Consumption
(PROB2)
What this study is about
This study proposes a 16-week, between-subject, where neither patients nor doctors know which treatment is given, randomly assigned controlled trial (RCT) with probenecid (2g /day) compared to placebo in individuals with AUD to test if reduces craving and alcohol consumption.
View original scientific description
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.
Interventions
DRUG
Probenecid Oral Tablet
2gr daily
DRUG
Placebo Oral Tablet
Inactive compound
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations