Trial · NCT04218357
Probenecid as Medication for Alcohol Use Disorder (PROB)
NCT04218357, Phase 1, Completed, Brown University; results first posted 2025-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Probenecid as Medication for Alcohol Use Disorder (PROB). Trials, record NCT04218357. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04218357
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Probenecid as Medication for Alcohol Use Disorder (PROB)
- NCT number
- NCT04218357
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 35 participants, actual
- Lead sponsor
- Brown University
- Conditions
- Alcohol Use Disorder
- Interventions
- Probenecid or placebo single administration
- First posted
- 2020-01-06
- Last updated
- 2025-02-27
- Results first posted
- 2025-02-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo | 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. |
| Secondary | Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). | 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. |
| Secondary | Alcohol Craving | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). | scores on scale | MEAN | |
| SECONDARY | Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). | scores on scale | MEAN | |
| SECONDARY | Alcohol Craving | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). | score on scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo | Matching Placebo | Ascending alcohol BrAC | 28.23 | Standard Deviation 21.82 | scores on scale |
| Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo | Probenecid | Ascending alcohol BrAC | 25.26 | Standard Deviation 20.66 | scores on scale |
| Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo | Matching Placebo | Descending alcohol BrAC | 20.57 | Standard Deviation 18.95 | scores on scale |
| Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo | Probenecid | Descending alcohol BrAC | 19.56 | Standard Deviation 20.33 | scores on scale |
| Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo | Matching Placebo | Ascending limb of BrAC | 16.02 | Standard Deviation 14.21 | scores on scale |
| Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo | Probenecid | Ascending limb of BrAC | 16.79 | Standard Deviation 15.17 | scores on scale |
| Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo | Matching Placebo | Descending limb of BrAC | 16.26 | Standard Deviation 15.27 | scores on scale |
| Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo | Probenecid | Descending limb of BrAC | 16.50 | Standard Deviation 15.15 | scores on scale |
| Alcohol Craving | Matching Placebo | Ascending limb of BrAC | 23.09 | Standard Deviation 13.23 | score on scale |
| Alcohol Craving | Probenecid | Ascending limb of BrAC | 17.24 | Standard Deviation 10.47 | score on scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1st Allocation | STARTED | Matching Placebo, Then Probenecid | 18 | |
| 1st Allocation | STARTED | Probenecid, Then Matching Placebo | 17 | |
| 1st Allocation | COMPLETED | Matching Placebo, Then Probenecid | 17 | |
| 1st Allocation | COMPLETED | Probenecid, Then Matching Placebo | 17 | |
| 1st Allocation | NOT COMPLETED | Matching Placebo, Then Probenecid | 1 | |
| 1st Allocation | NOT COMPLETED | Probenecid, Then Matching Placebo | 0 | |
| 2nd Allocation (Cross Over) | STARTED | Matching Placebo, Then Probenecid | 17 | |
| 2nd Allocation (Cross Over) | STARTED | Probenecid, Then Matching Placebo | 17 | |
| 2nd Allocation (Cross Over) | COMPLETED | Matching Placebo, Then Probenecid | 17 | |
| 2nd Allocation (Cross Over) | COMPLETED | Probenecid, Then Matching Placebo | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Matching Placebo | 0 | 35 |
| Total, all-cause mortality | Probenecid | 0 | 34 |
| Total, other adverse events | Matching Placebo | 0 | 35 |
| Total, other adverse events | Probenecid | 0 | 34 |
| Total, serious adverse events | Matching Placebo | 0 | 35 |
| Total, serious adverse events | Probenecid | 0 | 34 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Probenecid vs Matching Placebo: deaths from any cause | Trial comparisons |
| Probenecid vs Matching Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04218357
GET https://conductscience.org/api/trials/v1/NCT04218357/registered