Probenecid Administration for Alcohol Craving and Consumption

Not Applicable

Not yet recruiting

• Conditions: Alcohol Use Disorder (AUD); Alcohol Consumption; Craving
• Interventions: Drug: Probenecid Oral Tablet; Drug: Placebo Oral Tablet

• Registration Number: NCT07118618
• Lead Sponsor: Brown University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Study Start: 2025-09-30
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study drug	Probenecid Oral Tablet	Probenecid 2gr oral
Placebo	Placebo Oral Tablet	Placebo inactive

Primary Outcome Measures

Name	Time	Method
Acute Alcohol Craving	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 Outcome Measures

Name	Time	Method
Alcohol craving	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.