Safety of acamprosate for alcohol use disorder Post-Liver transplant: a pilot randomized controlled trial.
Liver Transpl
; 2024 Sep 03.
Article
en En
| MEDLINE
| ID: mdl-39225670
ABSTRACT
INTRODUCTION:
Acamprosate is a therapy for alcohol use disorder but data on feasibility and safety in liver transplant (LT) recipients are lacking.METHODS:
This was a single-center unblinded prospective pilot randomized controlled trial of adults (≥18 years) with LT for ALD enrolled between 2021-2023 who were randomized 21 to the intervention of acamprosate (666mg dose three times daily) or standard of care (SOC) over 14 weeks. Outcomes included safety [prevalence of adverse events (AE)], feasibility (weekly survey response rate >60%), adherence (self-reported acamprosate use>60%), and efficacy (reduction in Penn Alcohol Craving Scale [PACS]) and relapse-blood phosphatidylethanol≥20ng/mL/reported alcohol use) evaluated by standardized weekly surveys. The efficacy analysis was done in both the intention to treat (ITT) (excluding withdrawals before medication administration) and per-protocol (PP) population (excluding withdrawals/<4 weeks participation).RESULTS:
Of 78 participants approached, 30 enrolled (19 acamprosate, 11 SOC) with similar baseline characteristics. Eight participants withdrew (6 acamprosate prior to medication administration and 2 SOC). AEs were similar between acamprosate and SOC groups (92.3% vs. 90.0%, p>0.99), including Grade 3 AEs (53.9% vs. 60.0%, p>0.99) with no reported grade 4/5 AEs. Survey response rates were similar in acamprosate vs SOC groups (61.0% vs. 76.0%, p=0.19), and 69.0% were acamprosate adherent. Baseline PACS values were low with no difference by group in median absolute change in PACS for ITT (0, IQR-4-0 vs. 0, IQR0-0, p=0.32) and PP analyses (-1, IQR-6-0 vs. 0, IQR0-0, p=0.36). There were no reported or biochemical evidence of alcohol relapse.CONCLUSION:
In this pilot study, preliminary data suggests that acamprosate may be safe and feasible. These data can inform larger studies and clinician efforts to address alcohol use disorder in post-LT care. (ClinicalTrials.gov, Number NCT06471686).
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Base de datos:
MEDLINE
Idioma:
En
Revista:
Liver Transpl
Asunto de la revista:
GASTROENTEROLOGIA
/
TRANSPLANTE
Año:
2024
Tipo del documento:
Article