Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations
NCT Number: NCT06471686
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alcohol Use Disorder|Liver Transplant; Complications
Interventions: DRUG: Acamprosate
Sponsor: University of Southern California
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-01
Completion Date: 2023-10-30
Locations: University of Southern California, Los Angeles, California, 90033, United States

Summary:
Acamprosate for alcohol use disorder may benefit liver transplant (LT) recipients with alcohol-associated liver disease (ALD), yet data on feasibility and safety in LT recipients are lacking. This was a single-center unblinded randomized controlled trial of adults (≥18 years) with LT for ALD enrolled between 2021-2023 who were randomized 2:1 to the intervention of acamprosate (666mg dose three time daily) or standard of care (SOC) for 14 weeks. The primary outcome was safety \[prevalence of adverse events (AE)\]. Secondary outcomes included feasibility (weekly survey response rate \>60%), adherence (self reported acamprosate use\>60%), and efficacy (reduction in Penn Alcohol Craving Scale \[PACS\]) and relapse). Relapse was defined as blood phosphatidylethanol≥20ng/mL or reported alcohol use. All analyses were done in the intention to treat (ITT) population and per-protocol population (PPP) (excluding withdrawals/acamprosate non-adherent).

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], prevalence of adverse events (AE) by common toxicity criteria, 14 weeks|Incidence of Treatment-Emergent Liver Test Changes, prevalence of liver test abnormalities \[aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, 14 weeks
Secondary Outcome Measures: Proportion of participants with weekly survey response rate >60%, Feasibility was defined as a response rate \>60% to weekly surveys in both treatment groups, 14 weeks|Rate of acamprosate usage> 60%, Adherence to acamprosate was measured via self-reported total milligrams of acamprosate taken weekly. Participants were deemed adherent to acamprosate to if they utilized it as prescribed for ≥60% of weeks (9 of 14 weeks)., 14 weeks|Change in alcohol cravings, Cravings were assessed using the validated survey Penn Alcohol Craving Scale . This is a 5 item Likert scale to measure cravings to drink alcohol within the past week with total scores ranging from 0-30. PACS scores were summarized in 4-week increments with the highest PACS score within +/- 2 weeks reported when missing at the specific time point. The median change in baseline PACS score was utilized in the analysis., 14 weeks|change in alcohol use, Alcohol use was assessed using a modified Timeline Followback (TFLB) which is a calendar-based method to examine variability, pattern, and extent of drinking using dates to enhance recall within the past 90 days prior to enrollment at baseline and then weekly thereafter until completion of the study. number of standard alcohol drinks per day were calculated based upon the above data., 14 weeks