NCT04107051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
533

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2024

Completed
Last Updated

March 21, 2025

Status Verified

February 1, 2025

Enrollment Period

3.4 years

First QC Date

September 24, 2019

Last Update Submit

March 19, 2025

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)

    1 year

Interventions

Nalmefene Hydrochloride HydrateDRUG

Oral administration of nalmefene hydrochloride hydrate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with alcohol dependence who are planned to be newly started on nalmefene hydrochloride hydrate for the treatment of reduction of alcohol consumption.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otsuka Pharmaceutical Co., Ltd.

Osaka, Japan

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Yasuhiko Fukuta, PhD

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 27, 2019

Study Start

October 1, 2019

Primary Completion

February 7, 2023

Study Completion

February 6, 2024

Last Updated

March 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)