UMIN-CTR Clinical Trial

Public title

Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists

Acronym

Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists

Scientific Title

Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists

Scientific Title:Acronym

Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists

Region

Japan

Condition

Alcoholic Liver Injury, Alcohol Dependence

Classification by specialty

Medicine in general	Hepato-biliary-pancreatic medicine	Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Long-term excessive alcohol consumption is a cause of alcoholic hepatitis and cirrhosis, and prognosis has been reported to improve with abstinence from alcohol. On the other hand, the rate at which abstinence from alcohol can be achieved is low and the rate of relapse is high. Nalmefene is a drug that reduces alcohol consumption in alcohol-dependent patients by suppressing the desire to drink through the modulation of opioid receptors that are widely present in the central nervous system. Unlike existing abstinence drugs, nalmefene is designed to reduce alcohol consumption and has been proven to reduce alcohol consumption for long time and to achieve subsequent sobriety, but its effects on improving liver function, adherence, and quality of life in patients with alcoholic liver disease have not been reported.
In addition, many patients with alcoholic liver disease have co-occurring alcoholism, but only 22% of respondents have "ever received psychiatric treatment for alcoholism," and psychiatric bridges have not been realistically established. Nalmefene is a drug that can be prescribed by physicians who have taken a training course. The treatment is started in internal medicine for patients who wish to reduce their alcohol consumption but have been unsuccessful in abstinence. Then, a bridge to psychiatric treatment can be made, which may lead to higher treatment efficacy.
The efficacy of nalmefene in patients with alcoholic liver disease should be confirmed by evaluating whether or not they can achieve sobriety and whether or not their liver function improves when they do achieve sobriety. If the efficacy of nalmefene can be shown in patients who are currently unable to abstain from alcohol, it will contribute to the improvement of liver function in more patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in Aspartate aminotransferase (AST) after 12, 24 weeks

Key secondary outcomes

Change in the following parameters after 12.24 weeks
Changes in liver function (ALT, albumin, gamma-glutamyl transpeptidase, Albumin-Bilirubin score, Cihld-Pugh Score)
Alcohol consumption (average alcohol consumption, heavy drinking days, days off drinking)
Incidence of events requiring hospitalization
Medication adherence rate
Degree of alcohol dependence (AUDIT)
Quality of life (A-QOL) based on a questionnaire index
Well-being (Clinical Global Impression-Severity of Illness: CGI-S)
Incidence of adverse events

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients 20 years of age or older,
Patients with alcoholic liver disease diagnosed as alcohol dependence based on DSM-IV-TR ICD-10.
Patients who have decided to start treatment with nalmefene,
Patients who understand the study and have given written consent.
Patients who have difficulty abstaining from alcohol but are willing to try to reduce alcohol consumption on their own.

Key exclusion criteria

Patients with a history of hypersensitivity to the nalmefene component.
Patients receiving opioids (analgesics, anesthetics) or within 1 week of discontinuation of opioid therapy
Patients with acute symptoms of opioid dependence or withdrawal
Patients who wish to be excluded from the study,
Patients who cannot provide written consent
Patients experiencing withdrawal symptoms, depressive symptoms or suicide attempts.
Patients deemed inappropriate by the attending physician or principal/assistant investigator

Target sample size

50

Name of lead principal investigator

1st name	Masatoshi
Middle name
Last name	Ishigami

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

466-8550

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-741-2111

Email

mtfujish@med.nagoya-u.ac.jp

Name of contact person

1st name	Kenta
Middle name
Last name	Yamamoto

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

466-8550

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-741-2111

Homepage URL

Email

kenta-y@med.nagoya-u.ac.jp

Institute

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan

Tel

052-741-2111

Email

052-741-2111

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学医学部附属病院(愛知県)

Date of disclosure of the study information

2022

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2022

Year

06

Month

27

Day

Date of IRB

Anticipated trial start date

2022

Year

09

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

observational study

Registered date

2022

Year

06

Month

27

Day

Last modified on

2022

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054906