UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057927 |
|---|---|
| Receipt number | R000066219 |
| Scientific Title | A Survey on Drinking and Alcohol-Related Problems Among Drivers with License Revocation Due to Drunk Driving |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/05/21 11:58:30 |
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Basic information
Public title
Survey on alcohol-related problems among drunk drivers
Acronym
Survey on alcohol-related problems among drunk drivers
Scientific Title
A Survey on Drinking and Alcohol-Related Problems Among Drivers with License Revocation Due to Drunk Driving
Scientific Title:Acronym
Survey on Alcohol Use and Problems in Drivers with Revoked Licenses for Drunk Driving
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the characteristics and backgrounds of drunk drivers and estimate the prevalence of suspected alcohol use disorder among attendees of a license revocation program.
Basic objectives2
Others
Basic objectives -Others
Assessing the current situation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alcohol Use Disorders Identification Test (AUDIT)
Key secondary outcomes
Driving behavior prior to license revocation (frequency, purpose, mileage, history of drunk driving, etc.)
History of alcohol-related medical conditions
Knowledge and perceptions regarding drunk driving
Screening test for Alcohol Use Disorder based on DSM-5 criteria
Drinking Motives Questionnaire Revised (DMQ-R)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals currently attending the educational program for drivers whose licenses have been revoked due to alcohol-related offenses.
2. Men and women aged 18 years or older.
3. Individuals who have the capacity to consent, have been fully informed of the purpose and content of the study, and voluntarily agree to participate after sufficient understanding.
Key exclusion criteria
1. Individuals under 18 years of age attending the educational program for drivers whose licenses have been revoked due to alcohol-related offenses.
2. Individuals who do not provide informed consent to participate in the study.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Sachio |
| Middle name | |
| Last name | Matsushita |
Organization
National Hospital Organization Kurihama Medical and Addiction Center
Division name
Psychiatry
Zip code
239-0841
Address
5-3-1, Nobi, Yokosuka-shi, Kanagawa
TEL
0468481550
sachio-m@wa2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Koga |
Organization
National Hospital Organization Kurihama Medical and Addiction Center
Division name
Department of Clinical Research
Zip code
2390841
Address
5-3-1, Nobi, Yokosuka-shi, Kanagawa
TEL
0468481550
Homepage URL
koga.kmac@gmail.com
Sponsor or person
Institute
National Hospital Organization Kurihama Medical and Addiction Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kurihama Medical and the Addiction Center Ethics Committee
Address
5-3-1, Nobi, Yokosuka-shi, Kanagawa
Tel
0468481550
220-kanrikachou@mail.hosp.go.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
| 2025 | Year | 06 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Consent for cooperation has been obtained from the organization conducting the educational program. The survey will begin as soon as the questionnaires and related materials are prepared.
Management information
Registered date
| 2025 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066219
