Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence

Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04107051

Enrollment

533

Registered

2019-09-27

Start date

2019-10-01

Completion date

2024-02-06

Last updated

2025-03-21

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

Conditions

Alcohol Dependence

Brief summary

The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine clinical setting in Japan.

Interventions

DRUGNalmefene Hydrochloride Hydrate

Oral administration of nalmefene hydrochloride hydrate

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of Alcohol Dependence * Must agree to follow-up during the first year of prescription and publication of survey results * Patients whose goal of treatment for Alcohol Dependence is to reduce alcohol consumption * Patients receiving psychosocial treatment aiming to promote treatment adherence and reduction of alcohol consumption * Patients who have chronic heavy drinking * Patients who have confirmed that they are willing to receive treatment to reduce their alcohol consumption

Exclusion criteria

* Patients who has ever been treated with nalmefene hydrochloride hydrate * Patients who are contraindicated

Design outcomes

Primary

Measure	Time frame
Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)	1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026