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

Otsuka

Status: Completed

Conditions: Alcohol Dependence

Treatments: Drug: Nalmefene Hydrochloride Hydrate

Study type: Observational

Funder types: Industry

Identifiers

NCT04107051

339-101-00015

Details and patient eligibility

About

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.

Enrollment: 533 patients

Sex: All

Volunteers: No 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