UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of cognitive function and driving skill after alcohol intake Part2
Title of the study (Brief title)	Examination of cognitive function and driving skill after alcohol intake Part2
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Targeting Japanese, we observe how much the expiration alcohol level correlates with cognitive function testing and whether could be index of a cognitive function for safe driving.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. The comparison of the score for DSST, TMT Pert A and B between before intake alcohol and after intake alcohol 2. The comparison of the score for evaluation for rehabilitation driving ability before intake alcohol and after intake alcohol
Key secondary outcomes	Examination of software cognitive function score before and after alcohol consumption

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	The group taken with Alcohol
Interventions/Control_2	The group do not taken with Alcohol
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	1) The healthy person who is from 20 years old to 65 years old and can intake alcohol with an examination and agrees 2) The person who has a driver's license 3) The person who can come to the hospital using public transport or on foot on the study day 4) The person who understand enough the explanation about taking this examination and agrees on this study
Key exclusion criteria	1) The person who takes the medicine which influences on one's cognitive function such as an antihistamine, the sleep inducing drug 2) Woman who is pregnant or pregnant possibilities, a woman who is nursing 3) The person whom AUDIT score is over eight points. 4) The person who took perform Tokyo University-type ALDH2 and score less than 0 point. 5) The person smokes 6) The person who has liver dysfunction pointed out 7)The person who is seen as a inappropriate by a doctor who is in charge of the examination
Target sample size	41

Research contact person
Name of lead principal investigator	Michiho Sodenaga
Organization	St. Marianna University School Of Medicine
Division name	Neuropsychiatry
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	044-977-8111
Email	m2sode@marianna-u.ac.jp

Public contact
Name of contact person	Kenichi Osada
Organization	St. Marianna University School Of Medicine
Division name	Neuropsychiatry
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	044-977-8111
Homepage URL
Email	k2osada@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School Of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School Of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 24 Day
Anticipated trial start date	2015 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 07 Month 27 Day
Last modified on	2018 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038244