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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000024
Receipt No. R000000056
Scientific Title Smoking cessation program using nicotine replacement therapy for adolescent smokers: A randomized trial
Date of disclosure of the study information 2005/09/01
Last modified on 2005/08/22

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Basic information
Public title Smoking cessation program using nicotine replacement therapy for adolescent smokers: A randomized trial
Acronym Smoking cessation program using nicotine replacement therapy for adolescent smokers: A randomized trial
Scientific Title Smoking cessation program using nicotine replacement therapy for adolescent smokers: A randomized trial
Scientific Title:Acronym Smoking cessation program using nicotine replacement therapy for adolescent smokers: A randomized trial
Region
Japan

Condition
Condition Adolescent smokers aged under 20 years old with nicotine dependence
Classification by specialty
Medicine in general Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hypothesis: Nicotine replacement therapy in the course of the smoking cessation program is effective and safe enough to be applied to adolescent smokers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of smoking abstinence during the followup at 1 month, 3 months and 6 months after beginning the nicotine replacement therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group: Attending the smoking cessation program without nicotine replacement therapy
Interventions/Control_2 Intervention group: Attending the smoking cessation program followed by nicotine replacement therapy with nicotine patches for 7 consecutive days
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

Not applicable
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria Adolescent smokers aged under 20 years old who want to quit smoking. They must be verified as smokers by one or more of following three tests; Fagerstrom Tolerance Questionnair, nicotine urinalysis or expired CO concentration.
Key exclusion criteria Those who are not verified as smokers. In the case where we can not get consent from his or herself or their guardians.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Tsuji
Organization Kanagawa prefecture
Division name Kamakura health and welfare center
Zip code
Address 2-16-13 Yuigahama Kamakura-city Kanagawa, Japan
TEL 0467-24-3900
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanagawa prefecture
Division name Kamakura health and welfare center
Zip code
Address 2-16-13 Yuigahama Kamakura-city Kanagawa, Japan
TEL 0467-24-3900
Homepage URL
Email

Sponsor
Institute Study group of smoking cessation program for adolescent smokers in Kamakura health and welfare center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2005 Year 09 Month 01 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
Date of protocol fixation
2005 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2006 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 07 Month 13 Day
Last modified on
2005 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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