UMIN-CTR Clinical Trial

Basic information
Public title	Effects of nalmefen on alcohol consumption in patients with alcoholic liver injury and alcohol-dependent patients
Acronym	Effects of nalmefen in patients with alcoholic liver injury and alcohol-dependent patients
Scientific Title	Effects of nalmefen on alcohol consumption in patients with alcoholic liver injury and alcohol-dependent patients
Scientific Title:Acronym	Effects of nalmefen in patients with alcoholic liver injury and alcohol-dependent patients
Region	Japan

Condition
Condition	alcoholic liver injury
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, the option of a reduced drinking setting (harm reduction) has been presented as an intermediate goal for patients who need to abstain from alcohol, and nalmefene was approved as a drinking reduction drug in January 2019. There are few reports that have comprehensively investigated the effects of nalmefene in alcoholic patients with alcoholic liver disease from both central and peripheral organs. In addition, the FRQ of the 3rd edition of the Guidelines for the Treatment of Cirrhosis states that the effect of harm reduction in patients with alcoholic cirrhosis needs to be investigated. In the present study, we will investigate the effects of nalmefene on the treatment of alcohol-related liver disorders, including alcoholic cirrhosis, and the factors associated with these effects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Liver reserve capacity at each time point.
Key secondary outcomes	Various blood biochemical indices related to liver injury (continuous variables)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Yoshiji
Organization	Nara medical university Hospital
Division name	Department of Gastroenterology
Zip code	634-8522
Address	840 Shijo-cho, Kashihara Nara
TEL	0744223051
Email	tadashin@naramed-u.ac.jp

Public contact
Name of contact person	1st name Tadashi Middle name Last name Namisaki
Organization	Nara medical university Hospital
Division name	Department of Gastroenterology
Zip code	634-8522
Address	840 Shijo-cho, Kashihara Nara
TEL	0744223051
Homepage URL
Email	tadashin@naramed-u.ac.jp

Sponsor
Institute	Nara medical university Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization	self-financing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara medical university Hospital
Address	840 Shijo-cho, Kashihara Nara
Tel	0744223051
Email	tadashin@naramed-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2022 Year 06 Month 14 Day
Date of IRB	2022 Year 06 Month 14 Day
Anticipated trial start date	2022 Year 06 Month 14 Day
Last follow-up date	2025 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	not paticular

Management information
Registered date	2022 Year 06 Month 14 Day
Last modified on	2022 Year 06 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053011

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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