Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Liver Test Changes
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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.
排除标准
- •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
研究组 & 干预措施
Acamprosate
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
干预措施: Acamprosate (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Liver Test Changes
时间窗: 14 weeks
prevalence of liver test abnormalities \[aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 14 weeks
prevalence of adverse events (AE) by common toxicity criteria
次要结局
- Rate of acamprosate usage> 60%(14 weeks)
- Proportion of participants with weekly survey response rate >60%(14 weeks)
- Change in alcohol cravings(14 weeks)
- change in alcohol use(14 weeks)
研究者
Hyosun Han
Assistant Professor of Clinical medicine
University of Southern California