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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014742
Receipt No. R000017138
Scientific Title Examination of cognitive function and driving skill after alcohol intake.
Date of disclosure of the study information 2014/08/08
Last modified on 2018/10/10

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Basic information
Public title Examination of cognitive function and driving skill after alcohol intake.
Acronym Examination of cognitive function and driving skill after alcohol intake.
Scientific Title Examination of cognitive function and driving skill after alcohol intake.
Scientific Title:Acronym Examination of cognitive function and driving skill after alcohol intake.
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Psychiatry Adult
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 Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Alcohol
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
65 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 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
1st name
Middle name
Last name Kenichi Osada
Organization St. Marianna University School Of Medicine
Division name Neuropsychiatry
Zip code
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
1st name
Middle name
Last name Kenichi Osada
Organization St. Marianna University School Of Medicine
Division name Neuropsychiatry
Zip code
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 None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 08 Month 08 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 Completed
Date of protocol fixation
2014 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 01 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/ctr_e/ctr_view.cgi?recptno=R000017138

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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