UMIN-CTR Clinical Trial

Basic information
Public title	Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Acronym	Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Scientific Title	Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Scientific Title:Acronym	Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The objective of this study was to evaluate the effect of alcohol on the brain of healthy Japanese men and women aged 20 years or older and less than 30 years old, using MRI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MRI-measured data (T1, DTI, 1H-MRS, resting fMRI) VAS score for subjective symptoms of drunkenness
Key secondary outcomes	Ethanol Acetaldehyde Acetic acid Lactic acid Pyruvic acid Hematocrit Plasma glucose Plasma vasopressin Plasma TGFBeta Plasma amino acid

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Alcohol clamping method
Interventions/Control_2	Alcohol clamping method Wash out Controlled Trial
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	30 years-old >
Gender	Male and Female
Key inclusion criteria	1.Age: 20 years or older, less than 30 years 2.Gender: Healthy Japanese men and women without disease 3.Right-handed person 4.Nonsmoker 5.Person who drink alcohol more frequently than once or twice a month. 6.Individuals with ALDH2 alcohol-susceptibility genes *1/*2
Key exclusion criteria	1.Patients with serious or past medical conditions of the heart, liver or kidney 2.Persons currently receiving continuous treatment with drugs 3.Persons with a history of drug or food allergy 4.Patients who are or have a history of treatment for drug dependence or abuse 5.Persons whose working hours are irregular, such as those who have worked at night 6.Subjects who are currently participating in another clinical study or have participated in another clinical study within the previous 3 months 7.Persons using cardiac pacemakers 8.Persons using vascular clips 9.Those using nerve electrical stimulators 10.Persons using implantable pumps 11.Persons in whom a piece of metal is in the body for some reason (including accidents and injuries) 12.Persons with tattoos (including one-point tattoos) 13.Persons with internal metal plates or screws for prostheses such as fractures 14.Other than the above, the investigator considered inappropriate for participation in the study
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Group Holdings,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.co.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	2018 Year 05 Month 29 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	18
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The supply of materials used for analysis and measurement was delayed.
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	Completed
Date of protocol fixation	2018 Year 05 Month 11 Day
Date of IRB	2018 Year 05 Month 21 Day
Anticipated trial start date	2019 Year 05 Month 13 Day
Last follow-up date	2020 Year 12 Month 19 Day
Date of closure to data entry	2020 Year 12 Month 21 Day
Date trial data considered complete	2020 Year 12 Month 21 Day
Date analysis concluded	2022 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 05 Month 29 Day
Last modified on	2022 Year 04 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037355