UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory investigation on the influence of the anti-drug abuse program "Dame! Zettai! (No Absolutely, No Drugs)" on the perception/understanding of medical narcotics
Acronym	An exploratory investigation on the influence of the anti-drug abuse program "Dame! Zettai! (No Absolutely, No Drugs)" on the perception/understanding of medical narcotics
Scientific Title	An exploratory investigation on the influence of the anti-drug abuse program "Dame! Zettai! (No Absolutely, No Drugs)" on the perception/understanding of medical narcotics
Scientific Title:Acronym	An exploratory investigation on the influence of the anti-drug abuse program "Dame! Zettai! (No Absolutely, No Drugs)" on the perception/understanding of medical narcotics
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct an exploratory investigation on the influence of the anti-drug abuse program "Dame! Zettai! (No Absolutely, No Drugs)" on the perception/understanding of medical narcotics
Basic objectives2	Others
Basic objectives -Others	An exploratory investigation on the influence of the anti-drug abuse program "Dame! Zettai! (No Absolutely, No Drugs)" on the perception/understanding of medical narcotics
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The proportion of respondents who answered "Do not want to use medical narcotics" among those who are aware of the anti-drug abuse program "Dame! Zettai! (No Absolutely, No Drugs)"
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Males and females who live in Japan and are aged 20 years or older at the time of obtaining consent 2) Gave online consent to participate in the survey
Key exclusion criteria	1) Has a past medical history of or is currently diagnosed with cancer or other malignancy 2) Has worked in or is currently working in any of the following industries or workplaces A) Broadcasting, newspapers, publishing, or media B) Advertising agency, marketing research company, or think tank organization C) Hospital, medical or health clinic, or pharmacy D) Pharmaceutical manufacturer or retailer
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Suzuki
Organization	Council for Promotion of Proper Pharmaceutical Use and Drug Abuse Prevention
Division name	Not applicable
Zip code	231-0027
Address	Kinga Building 1F, 1-1-25 Ogicho, Naka Ward, Yokohama, Kanagawa, Japan
TEL	045-550-3830
Email	info@cppjp.or.jp

Public contact
Name of contact person	1st name Tsutomu Middle name Last name Suzuki
Organization	Council for Promotion of Proper Pharmaceutical Use and Drug Abuse Prevention
Division name	Not applicable
Zip code	231-0027
Address	Kinga Building 1F, 1-1-25 Ogicho, Naka Ward, Yokohama, Kanagawa, Japan
TEL	045-550-3830
Homepage URL
Email	info@cppjp.or.jp

Sponsor
Institute	Council for Promotion of Proper Pharmaceutical Use and Drug Abuse Prevention
Institute
Department

Funding Source
Organization	Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shionogi & Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yoyogi Mental Clinic Research Ethics Committee
Address	3F, 4-26-11 Sendagaya, Shibuya Ward, Tokyo, Japan
Tel	03-5413-6662
Email	cns_jimu@triad-j.co.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	2020 Year 12 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	2020 Year 10 Month 20 Day
Date of IRB	2020 Year 12 Month 08 Day
Anticipated trial start date	2020 Year 12 Month 09 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 01 Month 31 Day
Date trial data considered complete	2021 Year 01 Month 31 Day
Date analysis concluded	2021 Year 01 Month 31 Day

Other
Other related information	Not applicable

Management information
Registered date	2020 Year 12 Month 08 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048713