Probenecid as Medication for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— PROB  

Official title:

Probenecid as Pharmacotherapy for Alcohol Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218357
• Other study ID #: 1908002524
• Status: Completed
• Phase: Phase 1
• Start date: December 2, 2020
• Est. completion date: May 20, 2023

Study information

• Verified date: March 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The design is a randomized, within-subject, crossover, double-blind, placebo-controlled human alcohol laboratory study with one oral dose of 2g probenecid or placebo administered in two laboratory sessions.

Description:

There will be a total of four study visits. Visit 1 is the screening for eligibility (medical and physical examination). On Visits 2 and 3, participants will undergo an alcohol laboratory session with a one week washout period before administering the alternate therapy. The study will conclude at Visit 4.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 20, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female, 21-70 (inclusive) years; women >7 drinks/week; men >14 drinks/week;

• meet any DSM-5 criteria score for AUD;

• 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 have a positive urine screen for pregnancy

• CrCl < 60mL/min

• Taking aspirin (salicylates may reduce effect of probenecid)

• Taking penicillin

• Taking methotrexate (may increase concentration)

• Taking other medications that may interact with probenecid

• History of suicide attempts in the last three years

• Current diagnosis of another substance disorder(s) other than nicotine, as assessed by self-reports and urine toxicology screen at baseline

• History of hypersensitivity to sulfa drugs

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Probenecid
safety
• Matching placebo
Placebo

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tunstall BJ, Lorrai I, McConnell SA, Gazo KL, Zallar LJ, de Guglielmo G, Hoang I, Haass-Koffler CL, Repunte-Canonigo V, Koob GF, Vendruscolo LF, Sanna PP. Probenecid Reduces Alcohol Drinking in Rodents. Is Pannexin1 a Novel Therapeutic Target for Alcohol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulant effects of alcohol when co-administered with drug or matching placebo	assessed using the change in the Biphasic Alcohol Effects Scale (BAES), scale 0-10 (direct and reverse score)	Change from Day 3 to day 10 of the trial
Secondary	Sedative effects of alcohol when co-administered with drug or matching placebo	assessed using change in the Biphasic Alcohol Effects Scale (BAES), scale 0-10 (direct and reverse score)	Change from Day 3 to day 10 of the trial
Secondary	Alcohol craving	assessed using change in the alcohol urge questionnaire (AUQ), scale 0-7 (7 worse outcome)	Change from Day 3 to day 10 of the trial