Probenecid Administration for Alcohol Craving and Consumption

ConditionsAlcohol Use Disorder (AUD)Alcohol Consumption Craving

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorBrown University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

• 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).

Trial design

Design model

Parallel

Treatments tested in this trial

Probenecid Oral Tablet
Drug
2gr daily
Placebo Oral Tablet
Drug
Inactive compound

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Study drugExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Acute Alcohol Craving

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)

Time frame

5- week

Secondary outcomes

Alcohol craving

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.

Time frame

12-week

Other outcomes

Alcohol consumption

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

Time frame

12-week

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

Source ClinicalTrials.gov

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