Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations

Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations

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).

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).

Inclusion Criteria:

• >18 years of age
• must have received a transplant for liver disease secondary to alcohol-associated hepatitis or alcohol-associated cirrhosis
• greater than 24 hours of abstinence.

Exclusion Criteria:

• patients with hypersensitivity to acamprosate calcium or any of its components
• severe renal impairment (creatinine clearance ≤30 mL/min)
• substance dependence other than THC, alcohol, or nicotine
• need for inpatient detoxification or inpatient treatment of alcohol use
• participation in a clinical trial within the past 60 days
• women of childbearing potential without a medically acceptable form of contraception