Alcohol Use Disorder (AUD)Phase 2PROB2NCT07118618
Probenecid Administration for Alcohol Craving and Consumption
A Phase 2 study testing Probenecid Oral Tablet in people with Alcohol Use Disorder (AUD) and Alcohol Consumption, run by Brown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcohol Consumption, Craving
- What is being tested?
- Probenecid Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown University
Providence, Rhode Island, 02903
Brian Gully, MA, alcohol-stress-study@brown.edu
About this study
Official title: Probenecid, Pannexin 1 Channels for Alcohol Use Disorder
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.
Read the detailed description
There are three aims in this study that test the hypothesis that probenecid compared to placebo, decreases:
- Aim 1 (laboratory phase): acute alcohol craving.
- Aim 2 (naturalistic phase): alcohol craving.
- Aim 3 (naturalistic phase): alcohol consumption
- Conditions
- Alcohol Use Disorder (AUD), Alcohol Consumption, Craving
- Being tested
- Probenecid Oral Tablet, Placebo Oral Tablet
- Keywords
- AUD, Probenecid, Craving, Alcohol
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probenecid Oral TabletDrug
Also called Probalan
2gr daily
Placebo Oral TabletDrug
Also called Matching Inactive Oral Tablet
Inactive compound
| Study group | Role | What they receive |
|---|---|---|
| Study drug | Experimental | Probenecid 2gr oral Receives: Drug: Probenecid Oral Tablet |
| Placebo | Placebo comparator | Placebo inactive Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5- week
Secondary outcomes (1)
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.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start14 Mar 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
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 Haass-Koffler, PharmD, PhD, Principal investigator, Brown Univiversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118618
- Sponsor's protocol ID
- STUDY00000881
- Acronym
- PROB2
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hornbacher 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probenecid, Pannexin 1 Channels for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07118618
- Acronym / sponsor ID
- PROB2 / STUDY00000881
- Conditions
- Alcohol Use Disorder (AUD), Alcohol Consumption, Craving
- Keywords
- AUD, Probenecid, Craving, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 14 Mar 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are three aims in this study that test the hypothesis that probenecid compared to placebo, decreases:
- Aim 1 (laboratory phase): acute alcohol craving.
- Aim 2 (naturalistic phase): alcohol craving.
- Aim 3 (naturalistic phase): alcohol consumption
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo
| Arm | Type | Receives |
|---|---|---|
| Study drug | Experimental | Drug: Probenecid Oral TabletProbenecid 2gr oral |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo inactive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Male or female, ≥18 years.
Key exclusion criteria (10 listed)
- • Women who are breastfeeding or positive urine test for pregnancy.
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 Oral TabletAlso: Probalan2gr daily | Drug | Study drug |
| Placebo Oral TabletAlso: Matching Inactive Oral TabletInactive compound | Drug | Placebo |
Primary outcome
Acute Alcohol Craving
Time frame: 5- week
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)
1 secondary outcome
Alcohol craving
Time frame: 12-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: 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
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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.
Carolina Haass-Koffler, PharmD, PhD principal investigator
Brown Univiversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probenecid Oral Tablet in people with Alcohol Use Disorder (AUD) and Alcohol Consumption, 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Gully, MA (401-863-6646, brian_gully@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Alcohol Craving (time frame: 5- week). 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 NCT07118618, which also lists 1 linked publication.
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 17 Mar 2026.