Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058891) titled 'Investigation of the Effects of Heavy Drinking Habits via Genetic Analysis of Self-Collected Samples' on Nov. 10.
Study Type:
Observational
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Heavy Drinking Habits -induced cognitive decline
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - To clarify the effects of heavy drinking by exploring gene expression in neuron cells derived from self-collected nasal swab samples of heavy drinkers and non-drinkers in their 20s.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Japanese men and women in their 20s at the time of written consent
2. AUDIT score of 15 or higher, or non-drinkers with an AUDIT score of 0
3. Received sufficient explanation of the study's purpose and content, demonstrated capacity to consent, voluntarily agreed to participate, and provided written consent
Key exclusion criteria - 1. Currently receiving medication or outpatient treatment for any serious illness (as-needed medication permitted)
2. Currently receiving treatment for, or with a history of, psychiatric disorders (e.g., depression) or sleep disorders
3. Blood donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to consent
4. History of feeling unwell or experiencing vasovagal reflex during blood collection
5. Difficulty in self-collecting nasal samples using a swab
6. Difficulty complying with survey questionnaire requirements
7. Currently participating in another clinical trial or planning to do so during the study period
8. Deemed unsuitable as a participant by the principal investigator for any other reason
Target Size - 10
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 04 Month 16 Day
Date of IRB - 2025 Year 04 Month 22 Day
Anticipated trial start date - 2025 Year 11 Month 11 Day
Last follow-up date - 2025 Year 11 Month 11 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067350
Disclaimer: Curated by HT Syndication.
