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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probenecid | Experimental | 2g probenecid, one pill by mouth once, for one day |
|
| matching placebo | Placebo Comparator | Placebo, one pill by mouth once, for one day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probenecid or placebo single administration | Drug | study drug administration with alcohol in the laboratory |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolina L Haass-Koffler, PHARMD, PHD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 20923 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31535696 | Result | 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. | |
| 39472130 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Matching Placebo, Then Probenecid | Study Drug one pill by mouth once, for one day Matching placebo: Placebo |
| FG001 | Probenecid, Then Matching Placebo | 2g probenecid, one pill by mouth once, for one day Probenecid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Allocation |
|
| ||||||||||||||||||
| 2nd Allocation (Cross Over) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Sample | Placebo, then probenecid one pill by mouth once, for one day or Probenecid then placebo one pill by mouth once, for one day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | scores on scale | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). |
|
Adverse events were monitored during two laboratory sessions, visits 2 and 3, at which time probenecid and placebo were administered.
We reported any of the following Adverse Events:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Matching Placebo | Placebo, one pill by mouth once, for one day Matching placebo: Placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolina Haass-Koffler, PharmD, PhD | Brown University | 4155191385 | carolina_haass-koffler@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2019 | Jul 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2019 | Oct 28, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2022 | Jul 22, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| 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). | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). |
| 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. |
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis of alcohol use disorder (AUD) by SCID-5 | Count of Participants | Participants |
|
| OG000 |
| Matching Placebo |
Placebo, one pill by mouth once, for one day Matching placebo: Placebo |
| OG001 | Probenecid | 2g probenecid, one pill by mouth once, for one day Probenecid: safety |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | scores on scale | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on scale | Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC). |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Probenecid | 2g probenecid, one pill by mouth once, for one day Probenecid: safety | 0 | 34 | 0 | 34 | 0 | 34 |
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| Sulfur Compounds |