UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061462 |
|---|---|
| Receipt number | R000070338 |
| Scientific Title | Association of tobacco product type and nicotine pouch use with smoking cessation success in a cessation program using a digital peer-support application and nicotine replacement therapy with nicotine gum and patches: Prospective observational study |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 10:06:57 |
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Basic information
Public title
Association of tobacco product type and nicotine pouch use with smoking cessation success in a cessation program using a digital peer-support application and nicotine replacement therapy with nicotine gum and patches
Acronym
Digital Peer-Support Smoking Cessation Study
Scientific Title
Association of tobacco product type and nicotine pouch use with smoking cessation success in a cessation program using a digital peer-support application and nicotine replacement therapy with nicotine gum and patches: Prospective observational study
Scientific Title:Acronym
Digital Peer-Support Smoking Cessation Study
Region
| Japan |
Condition
Condition
Current Smokers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether tobacco product type is associated with smoking cessation success and whether app use frequency is associated with smoking cessation success.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Smoking cessation success rate, defined as self-reported complete abstinence for at least 4 consecutive weeks at the end of the 12-week program
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Owns an iOS or Android smartphone.
-Enrolled in the company corporate health insurance program.
-Self-reported smoking of at least 1 cigarette per day, including novel tobacco products such as heated tobacco products and e-cigarettes.
Key exclusion criteria
-Non-smokers.
-Not using the app or does not own an iOS or Android smartphone.
-Not enrolled in the company corporate health insurance program.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Yosihara |
Organization
Kitasato University
Division name
Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
TEL
042-778-9305
yoshihara.shota@st.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Yoshiahra |
Organization
Kitasato University
Division name
Medical Sciences
Zip code
252-0373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa, JAPAN
TEL
0427789305
Homepage URL
yoshihara.shota@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Conflicts of interest were reviewed by the Kitasato University Conflict of Interest Committee and are appropriately managed.
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
Research Ethics Committee of Kitasato University School of Allied Health Sciences
Address
1-15-1 Kitazato, Minami-ku, Sagamihara, Kanagawa 252-0373, Japan
Tel
0427789602
a-soumu@kitasato-u.ac.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
| 2026 | Year | 05 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-arm prospective observational study.
Participants will take part in a 3-month smoking cessation program using a digital peer-support app and will complete questionnaires (including smoking status) at baseline and at 3 months (program end).
The primary outcome is the smoking cessation success rate.
Logistic regression analysis will be used to estimate the odds ratio for smoking cessation success.
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070338
