Clinical Trials Logo
  1. Home
  2. Alcohol Dependence
  3. NCT04107051
  4. Details
NCT04107051 Clinical Trial

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

Alcohol Dependence Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04107051
Other study ID # 339-101-00015
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date March 31, 2024

Study information
Verified date March 2023
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 533
Est. completion date March 31, 2024
Est. primary completion date February 7, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nalmefene Hydrochloride Hydrate
Oral administration of nalmefene hydrochloride hydrate

Locations
Country Name City State
Japan Otsuka Pharmaceutical Co., Ltd. Osaka

Sponsors (1)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) 1 year
See also
  Status Clinical Trial Phase
Completed NCT03340051 - Remote Alcohol Monitoring and Episodic Thinking N/A
Completed NCT02901041 - Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism Phase 3
Not yet recruiting NCT06444243 - Psilocybin-assisted Therapy for Alcohol Use Disorder Phase 2
Completed NCT02486900 - Neurofeedback & Alcohol Dependence N/A
Completed NCT02705898 - Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women N/A
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Completed NCT02197598 - Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use Phase 4
Recruiting NCT02385643 - The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients N/A
Completed NCT01828866 - Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Active, not recruiting NCT01182766 - New Treatment for Alcohol and Nicotine Dependence Phase 2/Phase 3
Completed NCT02193204 - Chronic Alcohol, Stress Inflammatory Response and Relapse Risk N/A
Completed NCT01342549 - Treatment Strategy for Alcohol Use Disorders in Veterans With TBI Phase 3
Completed NCT01176591 - HBPL Study of the Impact of the NK1 Antagonist Aprepitant Phase 2
Completed NCT01165541 - A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency Phase 2
Completed NCT00585780 - Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse Phase 1/Phase 2
Completed NCT01056484 - Mindfulness Meditation for Health Phase 2
Completed NCT00607620 - Disseminating Organizational SBI Services at Trauma Centers N/A
Completed NCT00884884 - Aripiprazole and Topiramate on Free-Choice Alcohol Use Phase 2/Phase 3
Completed NCT00463346 - Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism Phase 3