Alcohol Use DisorderPhase 1PROBNCT04218357
Probenecid as Medication for Alcohol Use Disorder (PROB)
A Phase 1 study of Alcohol Use Disorder, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2020to 20 May 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probenecid as Pharmacotherapy for Alcohol Use Disorder
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Probenecid or placebo single administration
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probenecid or placebo single administrationDrug
Also called Probalan
study drug administration with alcohol in the laboratory
| Study group | Role | What they receive |
|---|---|---|
| Probenecid | Experimental | 2g probenecid, one pill by mouth once, for one day Receives: Drug: Probenecid or placebo single administration |
| matching placebo | Placebo comparator | Placebo, one pill by mouth once, for one day Receives: Drug: Probenecid or placebo single administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo
The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES).
The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome).
The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
Measured: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
Secondary outcomes (2)
Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo
The sedative effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES).
The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the sedation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome).
The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
Measured: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
Alcohol Craving
Alcohol craving is assessed using change in the alcohol urge questionnaire (AUQ).
The Alcohol Urge Questionnaire (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).
Measured: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start2 Dec 2020
- Primary completion16 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina L Haass-Koffler, Brown University
- Investigators
- Carolina L Haass-Koffler, PHARMD, PHD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218357
- Sponsor's protocol ID
- 1908002524
- Acronym
- PROB
- Status last verified
- Feb 2025
- First submitted
- 1 Jan 2020
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31535696Hornbacher R, Gully BJ, Brown ZE, Brown JC, Magill M, Cioe PA, Swift RM, Sanna PP, Haass-Koffler CL. Probenecid as a pharmacotherapy for alcohol use disorder: A randomized placebo-controlled alcohol interaction trial. Alcohol Clin Exp Res (Hoboken). 2024 Dec;48(12):2391-2403. doi: 10.1111/acer.15470. Epub 2024 Oct 29.
PubMed 39472130
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probenecid as Pharmacotherapy for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04218357
- Acronym / sponsor ID
- PROB / 1908002524
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probenecid | Experimental | Drug: Probenecid or placebo single administration2g probenecid, one pill by mouth once, for one day |
| matching placebo | Placebo comparator | Drug: Probenecid or placebo single administrationPlacebo, one pill by mouth once, for one day |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probenecid or placebo single administrationAlso: Probalanstudy drug administration with alcohol in the laboratory | Drug | Probenecid, matching placebo |
Primary outcome
Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo
Time frame: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES). The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome). The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
2 secondary outcomes
Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo
Time frame: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
Alcohol Craving
Time frame: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31535696Tunstall 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 publication: PubMed 39472130Hornbacher R, Gully BJ, Brown ZE, Brown JC, Magill M, Cioe PA, Swift RM, Sanna PP, Haass-Koffler CL. Probenecid as a pharmacotherapy for alcohol use disorder: A randomized placebo-controlled alcohol interaction trial. Alcohol Clin Exp Res (Hoboken). 2024 Dec;48(12):2391-2403. doi: 10.1111/acer.15470. Epub 2024 Oct 29.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Alcohol Use Disorder (AUD), Alcohol Abstinence
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Active, not recruiting
Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina L Haass-Koffler, PHARMD, PHD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Alcohol Use Disorder, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo (time frame: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.