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Effects of nalmefen on alcohol consumption in patients with alcoholic liver injury and alcohol-dependent patients

Effects of nalmefen on alcohol consumption in patients with alcoholic liver injury and alcohol-dependent patients - Effects of nalmefen in patients with alcoholic liver injury and alcohol-dependent patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000048050
Enrollment
150
Registered
2022-06-15
Start date
2022-06-14
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

Interventions

None listed

Sponsors

Nara medical university Hospital Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients whose eligibility for treatment with nalmefene has been determined as the best treatment in the usual course of practice 2. patients between 20 and 80 years of age, regardless of gender 3. patients who have been diagnosed by a physician who has taken the training required of physicians when calculating the additional fee for inpatient medical management of severe alcoholism or the "e-learning training on the diagnosis and treatment of alcoholism" organized by the Japanese Society of Alcoholism and Alcohol Abuse Medicine and the Japanese Society of Hepatology. Patients with alcoholic liver disease (hepatic reserve of less than 10 points in Child-Pugh score) 4. 4. patients with a drinking risk level (DRL) of high or very high for more than 2 weeks 5. patients willing to receive ongoing psychosocial supportive therapy focused on treatment compliance and alcohol consumption reduction

Exclusion criteria

Exclusion criteria: 1. patients under 19 years old and over 80 years old 2. patients with physical withdrawal symptoms 3. Patients with cancer 4. Pregnant and lactating patients 5. patients using opioids other than nalmefene 6. Patients with severely impaired renal function (eGFR<30 ml/min/1.73m2) 7. Patients who have indicated their refusal to participate in the study 8. dementia (PS2 or higher) 9. patients with psychosis other than alcohol use dependence, who are regularly attending or being hospitalized by a neuropsychiatrist, and who are considered to be difficult to participate in the study 10. other patients who are judged to be ineligible by the investigators and subinvestigators of this study 11. Patients with other addictions 12. patients with intellectual disabilities 13. patients with cerebral organic mental disorder 14. patients with a history of taking Nalmefene (Nalmefene reinstatement) 15. patients with a history of treatment for alcohol dependence at a medical institution specializing in addiction 16. patients with psychiatric disorders other than alcohol dependence

Design outcomes

Primary

MeasureTime frame
Liver reserve capacity at each time point.

Secondary

MeasureTime frame
Various blood biochemical indices related to liver injury (continuous variables)

Countries

Japan

Contacts

Public ContactTadashi Namisaki

Nara medical university Hospital Department of Gastroenterology

tadashin@naramed-u.ac.jp0744223051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026