UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000024 |
|---|---|
| Receipt number | 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 16:51:44 |
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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
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
Sponsor or person
Institute
Study group of smoking cessation program for adolescent smokers in Kamakura health and welfare center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000056
