RECRUITINGPhase 2INTERVENTIONAL
Probenecid Administration for Alcohol Craving and Consumption
Probenecid, Pannexin 1 Channels for Alcohol Use Disorder
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- • 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 willing to sign a consent form and questionnaires in English at an 8th grade level.
Who Should NOT Join This Trial:
- • 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Probenecid Oral Tablet
2gr daily
DRUG
Placebo Oral Tablet
Inactive compound
Locations (1)
Brown University
Providence, Rhode Island, United States