Acamprosate Safe to Use in Individuals With Liver Disease.
- Conditions
- Alcohol-related Liver Disease
- Interventions
- Drug: Acomprosate
- Registration Number
- NCT04287920
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Is acamprosate safe to use in individuals with liver disease.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Alcohol-related liver disease and AUD, MELD-NA more than 20 Acomprosate The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20. Alcohol-related liver disease and AUD, MELD-NA less than 20 Acomprosate The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.
- Primary Outcome Measures
Name Time Method Adverse Event 24 weeks Number of adverse events reported
- Secondary Outcome Measures
Name Time Method Change in Alcohol Craving Baseline, week 24 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.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States