UMIN-ICDS Clinical Trial

Public title

Survey on public attitudes toward wastewater monitoring for illicit drugs

Acronym

Wastewater Monitoring Attitude Survey

Scientific Title

WBE Social Acceptability Study

Scientific Title:Acronym

Exploratory study on social acceptability and ethical and institutional issues toward the social implementation of wastewater-based epidemiology for illicit drugs

Region

Japan

Condition

Not applicable. This is a study of attitudes and perceptions toward wastewater-based epidemiology for illicit drug monitoring among general adult residents aged 18 years or older in the Kanto region of Japan.

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to examine social acceptability of wastewater-based epidemiology (WBE) for illicit drug monitoring among the general adult population in Japan. A cross-sectional online questionnaire survey will be conducted among adults aged 18 years or older living in the Kanto region. The study will explore acceptability of WBE for monitoring illicit drug use, major concerns, views on the use of survey results, normative attitudes toward people who use illicit drugs, prior awareness of wastewater monitoring, interest in drug-related issues, and trust in government and research institutions. The findings are expected to provide basic evidence for considering explanations, institutional design, data-use policies, and ethical safeguards needed for the future social implementation of WBE for illicit drug monitoring in Japan.

Basic objectives2

Others

Basic objectives -Others

To exploratorily assess social acceptability, concerns, and related factors regarding wastewater-based epidemiology for illicit drug monitoring.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The primary outcome is acceptability of wastewater monitoring for assessing illicit drug use. Acceptability will be measured at the time of a single online questionnaire survey using three five-point Likert-type items
1.Overall acceptability: agreement with the concept of wastewater monitoring to assess trends in illicit drug use at the community level.
2.Local acceptability: acceptability of implementing such monitoring in the respondent's own residential area.
3.Public-health-oriented acceptability: acceptability of implementing such monitoring when it is intended to inform public health measures, such as prevention education and support for people with substance use problems.

Key secondary outcomes

Key secondary outcomes are factors and attitudes potentially associated with acceptability of wastewater monitoring for illicit drug use.
These include prior awareness of wastewater monitoring, views on how the results should be used, major concerns, concerns about the image of the respondent's residential area, normative attitudes toward people who use illicit drugs, interest in illicit drug use and drug dependence issues, trust in government and research institutions, educational attainment, occupation, age, sex, and residential area.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Individuals aged 18 years or older at the time of consent
2. General residents living in the Kanto region of Japan, including Tokyo, Kanagawa, Saitama, Chiba, Ibaraki, Tochigi, and Gunma prefectures
3. Individuals who are able to complete an online questionnaire
4. Individuals who provide voluntary consent to participate in the study

Key exclusion criteria

1. Individuals who discontinue the questionnaire before completion
2. Responses with substantial missing data or inconsistencies
3. Suspected duplicate responses
4. Responses judged invalid by the survey company based on quality-control procedures
5. Individuals or responses judged inappropriate by the principal investigator

Target sample size

1500

Name of lead principal investigator

1st name	Satomi
Middle name
Last name	Mizuno

Organization

National Center of Neurology and Psychiatry

Division name

Department of Drug Dependence Research, National Institute of Mental Health

Zip code

187-8551

Address

4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan

TEL

042-341-2712

Email

siijimasiijima@ncnp.go.jp

Name of contact person

1st name	Satomi
Middle name
Last name	Mizuno

Organization

National Center of Neurology and Psychiatry

Division name

Department of Drug Dependence Research, National Institute of Mental Health

Zip code

1878553

Address

4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan

TEL

042-341-2712

Homepage URL

Email

siijimasiijima@ncnp.go.jp

Institute

National Center of Neurology and Psychiatry (NCNP)

Institute

Department

Personal name

Satomi Mizuno

Organization

The Kurata Grants by The Hitachi Global Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

None

Co-sponsor

None

Name of secondary funder(s)

Organization

National Center of Neurology and Psychiatry Ethics Committee

Address

4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan

Tel

042-341-2712

Email

ml_rinrijimu@ncnp.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立精神・神経医療研究センター（東京都）
National Center of Neurology and Psychiatry (Tokyo)

Date of disclosure of the study information

2026

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

0

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

No public sharing of individual participant data is planned.

IPD sharing Plan description

The questionnaire data obtained in this study will not contain directly identifiable personal information. The data may be used secondarily for future studies related to social acceptability, ethical issues, institutional design, or public health policy regarding wastewater-based epidemiology for illicit drug monitoring. Any secondary use or provision to other researchers will be conducted only after appropriate ethics review and institutional procedures, where required. Public sharing of an individual participant-level dataset is not planned.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

06

Month

26

Day

Date of IRB

2026

Year

06

Month

26

Day

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2027

Year

04

Month

30

Day

Date of closure to data entry

2027

Year

04

Month

30

Day

Date trial data considered complete

2027

Year

04

Month

30

Day

Date analysis concluded

2027

Year

04

Month

30

Day

Other related information

This is a prospective cross-sectional online questionnaire survey of general adult residents aged 18 years or older living in the Kanto region of Japan. Approximately 1,200 to 1,500 participants will be recruited from registered monitors of an online survey company using quota sampling by region, sex, and age group. The regional categories are Tokyo; Kanagawa, Saitama, and Chiba; and Ibaraki, Tochigi, and Gunma. Age groups are 18-29, 30-39, 40-49, 50-64, and 65 years or older. The outcome is acceptability of wastewater-based epidemiology for monitoring illicit drug use, assessed using five-point Likert-type items on overall acceptability, acceptability in the respondent's own residential area, and acceptability for public health purposes. Potentially related factors include prior awareness of wastewater monitoring, views on the use of survey results, major concerns, concerns about the image of the respondent's residential area, normative attitudes toward people who use illicit drugs, interest in illicit drug use and drug dependence issues, trust in government and research institutions, age, sex, residential area, educational attainment, and occupation. The analysis will describe response distributions and exploratorily examine associations between acceptability and related factors using cross-tabulations, chi-square tests, and logistic regression analyses as appropriate. This is a single-time-point questionnaire survey and involves no intervention, clinical examination, use of medical products or devices, or individual follow-up. The online survey company will conduct participant recruitment, questionnaire administration, response collection, and data provision. The researchers will not receive directly identifiable personal information, such as names, addresses, telephone numbers, or email addresses.

Registered date

2026

Year

06

Month

29

Day

Last modified on

2026

Year

06

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071040