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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048182

Enrollment

Registered

2022-06-30

Start date

2022-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Liver Injury, Alcohol Dependence

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 20 years of age or older, Patients with alcoholic liver disease diagnosed as alcohol dependence based on DSM-IV-TR ICD-10. Patients who have decided to start treatment with nalmefene, Patients who understand the study and have given written consent. Patients who have difficulty abstaining from alcohol but are willing to try to reduce alcohol consumption on their own.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Change in Aspartate aminotransferase (AST) after 12, 24 weeks	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactKenta Yamamoto

Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology

kenta-y@med.nagoya-u.ac.jp052-741-2111

Outcome results