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Probenecid as Medication for Alcohol Use Disorder (PROB)

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Probenecid
Matching placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brown UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probenecid

matching placebo

Arm Description

2g probenecid, one pill by mouth once, for one day

Placebo, one pill by mouth once, for one day

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Alcohol craving
assessed using change in the alcohol urge questionnaire (AUQ), scale 0-7 (7 worse outcome)

Full Information

First Posted
January 1, 2020
Last Updated
July 7, 2023
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT04218357
Brief Title
Probenecid as Medication for Alcohol Use Disorder
Acronym
PROB
Official Title
Probenecid as Pharmacotherapy for Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probenecid
Arm Type
Experimental
Arm Description
2g probenecid, one pill by mouth once, for one day
Arm Title
matching placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, one pill by mouth once, for one day
Intervention Type
Drug
Intervention Name(s)
Probenecid
Other Intervention Name(s)
Probalan
Intervention Description
safety
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Stimulant effects of alcohol when co-administered with drug or matching placebo
Description
assessed using the change in the Biphasic Alcohol Effects Scale (BAES), scale 0-10 (direct and reverse score)
Time Frame
Change from Day 3 to day 10 of the trial
Secondary Outcome Measure Information:
Title
Sedative effects of alcohol when co-administered with drug or matching placebo
Description
assessed using change in the Biphasic Alcohol Effects Scale (BAES), scale 0-10 (direct and reverse score)
Time Frame
Change from Day 3 to day 10 of the trial
Title
Alcohol craving
Description
assessed using change in the alcohol urge questionnaire (AUQ), scale 0-7 (7 worse outcome)
Time Frame
Change from Day 3 to day 10 of the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe Brown, BA
Phone
401-863-6646
Email
alcohol-stress-study@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina L Haass-Koffler, PHARMD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
20923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Brown
Phone
401-863-6646
First Name & Middle Initial & Last Name & Degree
Carolina Haass-Koffler, PHARMD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31535696
Citation
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 Use Disorder? Alcohol Alcohol. 2019 Jan 9;54(5):497-502. doi: 10.1093/alcalc/agz054.
Results Reference
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Probenecid as Medication for Alcohol Use Disorder

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