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Completed

NCT Number: NCT06471686

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).

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Liver Transplant; Complications Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Southern California

Los Angeles, California, 90033, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acamprosate

Drug

2 pills three times a day

Other names: acamprosate pills

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 14 weeks

    prevalence of adverse events (AE) by common toxicity criteria

  2. Incidence of Treatment-Emergent Liver Test Changes

    Time frame: 14 weeks

    prevalence of liver test abnormalities [aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin

Secondary outcomes

  1. Proportion of participants with weekly survey response rate >60%

    Time frame: 14 weeks

    Feasibility was defined as a response rate >60% to weekly surveys in both treatment groups

  2. Rate of acamprosate usage> 60%

    Time frame: 14 weeks

    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).

  3. Change in alcohol cravings

    Time frame: 14 weeks

    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.

  4. change in alcohol use

    Time frame: 14 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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