Probenecid Administration for Alcohol Craving and Consumption (PROB2)

Brown University

Status and phase: Not yet enrolling; Phase 2

Conditions: Alcohol Consumption; Alcohol Use Disorder (AUD); Craving

Treatments: Drug: Probenecid Oral Tablet; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07118618

STUDY00000881

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Study drug

Experimental group

Description:

Probenecid 2gr oral

Treatment:

Drug: Probenecid Oral Tablet

Placebo

Placebo Comparator group

Description:

Placebo inactive

Treatment:

Drug: Placebo Oral Tablet