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Is acamprosate safe to use in individuals with liver disease.
Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol-related liver disease and AUD, MELD-NA less than 20 | Experimental | The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. |
|
| Alcohol-related liver disease and AUD, MELD-NA more than 20 | Experimental | The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acomprosate | Drug | Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Number of adverse events reported | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alcohol Craving | Number of subjects who experienced a decrease or unchanged Pennsylvania Alcohol Craving Scale (PACS) score from baseline to week 24. Measured using self-reported questionnaire using Pennsylvania Alcohol Craving Scale (PACS). The PACS has 5 questions, where each question has six options presented in Likert Scales from 0 to 6, with 0 being the least and 6 being the highest possible option, thus the possible minimum and maximum values are 0 and 30, respectively. Higher score indicates a positive alcohol craving symptom. |
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Inclusion criteria:
Aged 21 or over
Diagnosis of alcohol-related liver disease and AUD.
Abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.
At study enrollment, initial MELD-Na score must be less than 20 for the five individuals enrolling in the first phase of the pilot safety assessment. The second phase of the pilot safety assessment will include individuals with a MELD-Na of 20 or more at enrollment.
Have capacity to provide consent themselves
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas A Simonetto | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40136257 | Derived | Wu T, Mousa OY, Kulai T, Larson C, Olofson A, Kamath PS, Shah VH, Taner T, Sanchez W, Simonetto DA. Safety of Acamprosate in Patients With Alcohol-Associated Liver Disease: A Single-Arm Phase 2 Trial. Mayo Clin Proc. 2025 Jun;100(6):954-961. doi: 10.1016/j.mayocp.2024.12.013. Epub 2025 Mar 26. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months |
| FG001 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Adverse Event | Number of adverse events reported | One MELD-NA less than 20 subject and four MELD-NA more than 20 subjects withdrew prior to initiating the study drug. Data was not collected nor analyzed for those 5 subjects | Posted | Number | adverse events | 24 weeks |
|
Adverse events were collected from baseline to end of study, approximately 24 weeks.
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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 | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas (Doug) A. Simonetto, M.D. | Mayo Clinic | 507-284-4824 | Simonetto.Douglas@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2022 | Oct 28, 2022 | Prot_SAP_000.pdf |
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| Baseline, week 24 |
| BG001 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months |
|
|
| Secondary | Change in Alcohol Craving | Number of subjects who experienced a decrease or unchanged Pennsylvania Alcohol Craving Scale (PACS) score from baseline to week 24. Measured using self-reported questionnaire using Pennsylvania Alcohol Craving Scale (PACS). The PACS has 5 questions, where each question has six options presented in Likert Scales from 0 to 6, with 0 being the least and 6 being the highest possible option, thus the possible minimum and maximum values are 0 and 30, respectively. Higher score indicates a positive alcohol craving symptom. | One MELD-NA less than 20 subject and four MELD-NA more than 20 subjects withdrew prior to initiating the study drug. Data was not collected nor analyzed for those 5 subjects | Posted | Count of Participants | Participants | Baseline, week 24 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Acamprosate: Acamprosate was administered orally and was dosed at 333 mg three times a day, if tolerated it was increased to 666 mg three times a day. Acamprosate was administered for a total of 3 months | 0 | 6 | 0 | 6 | 1 | 6 |
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