Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists

UMIN ID: UMIN000048182

Registered date:30/06/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Alcoholic Liver Injury, Alcohol Dependence
• Date of first enrollment: 2022/09/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in Aspartate aminotransferase (AST) after 12, 24 weeks
• Secondary Outcome: Change in the following parameters after 12.24 weeks Changes in liver function (ALT, albumin, gamma-glutamyl transpeptidase, Albumin-Bilirubin score, Cihld-Pugh Score) Alcohol consumption (average alcohol consumption, heavy drinking days, days off drinking) Incidence of events requiring hospitalization Medication adherence rate Degree of alcohol dependence (AUDIT) Quality of life (A-QOL) based on a questionnaire index Well-being (Clinical Global Impression-Severity of Illness: CGI-S) Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: Patients with a history of hypersensitivity to the nalmefene component. Patients receiving opioids (analgesics, anesthetics) or within 1 week of discontinuation of opioid therapy Patients with acute symptoms of opioid dependence or withdrawal Patients who wish to be excluded from the study, Patients who cannot provide written consent Patients experiencing withdrawal symptoms, depressive symptoms or suicide attempts. Patients deemed inappropriate by the attending physician or principal/assistant investigator

Related Information

• Primary Sponsor: Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
• Source(s) of Monetary Support: Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine