BIOSTATISTICS CORE
BIOSTATISTICS CORE
批准号:
8379273
负责人:
CHAP T. LE
金额:
$13.35万
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-09-15 至 2016-08-31
关键词:
AddressAutomobile DrivingBreathingCessation of lifeCigaretteConsumptionDataDependenceDiseaseDropsEquilibriumFamilyGoalsHealthIndividualInstructionLeadNicotineParticipantPlacebosPoliciesPsychological reinforcementSmokeSmokerSmokingSmoking BehaviorSmoking PreventionTimeTobaccoUrsidae FamilyWithdrawaladdictioncigarette smokinginnovationnicotine replacementprematuretobacco control
中文摘要
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英文摘要
Smoking remains a leading cause of preventable disease and premature death woridwide. Approximately 1
out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die
prematurely from tobacco-related illnesses. Nicotine is widely accepted as a necessary constituent in
tobacco driving use and dependence. A significant reduction in the nicotine content of cigarettes represents
an innovative regulatory strategy with the potential to markedly reduce consumption and lead to greater
likelihood of quitting. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA
to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes.
For such a policy to be implemented safely and successfully, a number of critical issues and questions must
be evaluated. One primary issue is to determine an appropriately low yield of nicotine content per cigarette
that is below the addictive 'threshold' of nicotine, while at the same time balances reduced withdrawal effects
and maximizes acceptability. Study 1 directly bears on this issue. Study 1 will assess three different low
nicotine yields (0.02, 0.06, 0.18 mg) over a 6-week period and the data generated will be used to select an
optimal nicotine yield for the remaining study in Project 1 and for Projects 2 and 3. A second major issue is
whether simultaneous nicotine replacement therapy (NRT) facilitates the transition to very low nicotine
content (VLNC) cigarettes. Recent evidence suggests that NRT may decrease use of VLNC cigarettes,
reduce the volume of smoke inhaled per cigarette, and reduce drop-out rate. Study 2 will compare the
effects of VLNC cigarettes in participants on 21 mg transdermal nicotine to another group that smokers
VLNC cigarettes while wearing a placebo patch. A third group smoking normal nicotine content cigarettes
and wearing placebo patches will be included as an additional control.
RELEVANCE (See instructions):
This project has two goals. Study 1 will determine the optimal yield for very low nicotine cigarettes that leads
to reduced smoking, but also minimal discomfort and maximal acceptability. Study 2 will determine if nicotine
replacement aids in the transition to very low nicotine cigarettes. Both studies will advance understanding of
the feasibility of using very low nicotine cigarettes to reduce the health burden of smoking.
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BIOSTATISTICS CORE
-
批准号:8153477
-
项目类别:
-
资助金额:$14.63万
-
财政年份:2011
-
负责人:CHAP T. LE
-
依托单位:
Clinical
-
批准号:8310804
-
项目类别:
-
资助金额:$21.87万
-
财政年份:2011
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负责人:CHAP T. LE
-
依托单位:
Clinical
-
批准号:7917913
-
项目类别:
-
资助金额:$11.85万
-
财政年份:2010
-
负责人:CHAP T. LE
-
依托单位:
Translational Therapy
-
批准号:7944907
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项目类别:
-
资助金额:$15.87万
-
财政年份:2009
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics & Informatics
-
批准号:7944906
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项目类别:
-
资助金额:$40.13万
-
财政年份:2009
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:10172130
-
项目类别:
-
资助金额:$29.4万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:8533763
-
项目类别:
-
资助金额:$13.88万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:8001179
-
项目类别:
-
资助金额:$10.98万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:6983610
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项目类别:
-
资助金额:$15.92万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:8998773
-
项目类别:
-
资助金额:$17.62万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:8321402
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项目类别:
-
资助金额:$10.65万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistic Core
-
批准号:6983713
-
项目类别:
-
资助金额:$5.15万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:8380849
-
项目类别:
-
资助金额:$15.8万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:10390391
-
项目类别:
-
资助金额:$17.03万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:9359456
-
项目类别:
-
资助金额:$7.0万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:8721717
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项目类别:
-
资助金额:$15.83万
-
财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Biostatistics Core
-
批准号:10613416
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项目类别:
-
资助金额:$17.37万
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财政年份:2005
-
负责人:CHAP T. LE
-
依托单位:
Core C: Design and Analysis Core
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批准号:6863478
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项目类别:
-
资助金额:$23.18万
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财政年份:2004
-
负责人:CHAP T. LE
-
依托单位:
CORE--DESIGN AND ANALYSIS
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批准号:6358482
-
项目类别:
-
资助金额:$23.67万
-
财政年份:2000
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负责人:CHAP T. LE
-
依托单位:
CORE--BIOSTATISTICS
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批准号:6315268
-
项目类别:
-
资助金额:$19.71万
-
财政年份:2000
-
负责人:CHAP T. LE
-
依托单位:
海外基金