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

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 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


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

Value
https://center6.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