A Phase 2 interventional study of Acomprosate in Alcohol-related Liver Disease, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's enrollment of 12 is below the median of 50 across 1,322 interventional studies indexed under Liver Diseases.
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Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Diagnosis of alcohol-related liver disease and AUD.
Exclusion criteria:
The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.
Drug: Acomprosate
The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.
Drug: Acomprosate
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
Adverse Event
Number of adverse events reported
Time frame: 24 weeks
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.
Time frame: Baseline, week 24
| Milestone | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 |
|---|---|---|
| Started | 6 | 6 |
| Completed | 5 | 2 |
| Not completed | 1 | 4 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 3 |
Number of adverse events reported
| adverse events | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 |
|---|---|---|
| Adverse Event | 0 | 1 |
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.
| Participants | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 |
|---|---|---|
| Change in Alcohol Craving | 3 | 1 |
Collected over Adverse events were collected from baseline to end of study, approximately 24 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Event | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 0/6 | 1/6 |
| Age, Continuous(years) | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | Total |
|---|---|---|---|
| Median | 48 (43.00 to 55.25) | 50 (41.75 to 56.75) | 50 (41.25 to 57.00) |
| Sex: Female, Male(Participants) | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Alcohol-related Liver Disease and AUD, MELD-NA Less Than 20 | Alcohol-related Liver Disease and AUD, MELD-NA More Than 20 | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
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