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

University of Southern California

Status and phase: Completed; Phase 2

Conditions: Liver Transplant; Complications; Alcohol Use Disorder

Treatments: Drug: Acamprosate

Study type: Interventional

Funder types: Other

Identifiers

NCT06471686

HS-19-00991

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Acamprosate

Experimental group

Description:

The intervention group was assigned to acamprosate 666 mg oral tablets three times daily in addition to routine medical care for 14 weeks. Once assigned to this group, participants underwent a medication reconciliation with a transplant pharmacist to ensure there were no drug-drug interactions and answer questions regarding the medication. The medication prescription was then sent by the principal investigator (HH) to the patient preferred pharmacy. The research assistants (KL and JA) would confirm that the medication was obtained. They then underwent weekly telemedicine visits with a research member for 14 weeks and filled out self-report surveys to evaluate cravings, alcohol use, and side effects

Treatment:

Drug: Acamprosate

Standard of Care

No Intervention group

Description:

The control group continued with what was considered routine medical care as indicated by their medical condition including frequency of clinic visits (ranging from 1-6 months dependent on time from transplant), frequency of laboratory draws (ranging from twice monthly to biannually dependent on time from transplant), and adjustment of LT related medications (i.e. immunosuppression and prophylaxis against communicable disease). They also underwent weekly telemedicine visits with a research member for 14 weeks and filled out self-report surveys to evaluate cravings, alcohol use, and side effects