UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046449 |
|---|---|
| Receipt number | R000053002 |
| Scientific Title | Effects of alcohol on emotion. |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2022/12/26 20:21:00 |
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Basic information
Public title
Effects of alcohol on emotion.
Acronym
Effects of alcohol on emotion.
Scientific Title
Effects of alcohol on emotion.
Scientific Title:Acronym
Effects of alcohol on emotion.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of alcohol on emotion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain waves
Key secondary outcomes
Body temperature
Breath alcohol concentration
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
1st:Drinking alcoholic beverages
2nd:Drinking non-alcoholic beverages
Interventions/Control_2
1st:Drinking non-alcoholic beverages
2nd:Drinking alcoholic beverages
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese subjects 20 years old or more and less than 29 years old who have written informed consent
(2) Individuals who can take alcoholic beverages
(3) Individuals who have given the written informed consent
Key exclusion criteria
(1) Individuals who plan to hazardous work such as driving a vehicle, or operating machineries on the day of study
(2) Individuals who cannot take alcoholic beverages, have no experience to take alcoholic beverages, are hypersensitive to alcohol, are pregnant, plan to become pregnant, are lactation, or have alcohol allergy symptoms
(3) Individuals who are judged by the principal investigator to be inappropriate for this study as subjects based on the results of the background investigation
(4) Individuals who have a chronic disease and use medicines continuously, or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, thyroid gland disease, adrenal gland disease, and/or metabolic disorder)
(5) Individuals who have a history of digestive disease affecting digestion and absorption, or have a history of digestive surgery
(6) Individuals who cannot stop intake of alcoholic beverages or alcohol-containing foods on the previous day and the day of study
(7) Individuals who regularly take medicines that can affect mental status
(8) Individuals who have a history or current condition of drug or alcohol dependence
(9) Individuals who have a history of mental illness or epilepsy
(10) Individuals with drug and/or food allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takehiko |
| Middle name | |
| Last name | Shimura |
Organization
Dentsu ScienceJam Inc.
Division name
President
Zip code
107-0052
Address
102 TRES Akasaka, 4-2-28 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-6435-5316
takehiko.shimura@jam.dentsu.co.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Shimura |
Organization
Dentsu ScienceJam Inc.
Division name
President
Zip code
107-0052
Address
102 TRES Akasaka, 4-2-28 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-6435-5316
Homepage URL
takehiko.shimura@jam.dentsu.co.jp
Sponsor or person
Institute
Dentsu ScienceJam Inc.
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
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
Ethical Review Committee of Dentsu ScienceJam Inc.
Address
102 TRES Akasaka, 4-2-28 Akasaka, Minato-ku, Tokyo, Japan
Tel
03-6435-5316
info@dentsusciencejam.com
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
| 2021 | Year | 12 | Month | 24 | 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
| 2021 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053002
