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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.
There are three aims in this study that test the hypothesis that probenecid compared to placebo, decreases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study drug | Experimental | Probenecid 2gr oral |
|
| Placebo | Placebo Comparator | Placebo inactive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probenecid Oral Tablet | Drug | 2gr daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 5- week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol consumption | Number of standard drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB) | 12-week |
Inclusion Criteria:
• Male or female, ≥18 years.
Exclusion Criteria:
• Women who are breastfeeding or positive urine test for pregnancy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Gully, MA | Contact | 401-863-6646 | brian_gully@brown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolina Haass-Koffler, PharmD, PhD | Brown Univiversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Recruiting | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39472130 | Background | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| 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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16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo
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| Placebo Oral Tablet | Drug | Inactive compound |
|
|
| 12-week |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| Sulfur Compounds |