BIOSTATISTICS CORE

生物统计学核心

• 批准号: 8153477
• 负责人: CHAP T. LE
• 金额: $ 14.63万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8153477
• 关键词: Address; Automobile Driving; Breathing; Cessation of life; Cigarette; Consumption; Data; Dependence; Disease; Drops; Equilibrium; Family; Goals; Health; Individual; Instruction; Lead; Nicotine; Participant; Placebos; Policies; Psychological reinforcement; Smoke; Smoker; Smoking; Smoking Behavior; Smoking Prevention; Time; Tobacco; Ursidae Family; Withdrawal; addiction; cigarette smoking; innovation; nicotine replacement; premature; tobacco control

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.

吸烟仍然是全球可预防疾病和过早死亡的主要原因。约1 每 5 例死亡均与吸烟有关，每天吸烟者中约有一半会死亡 过早地患上与烟草有关的疾病。尼古丁被广泛认为是人体必需的成分 烟草导致使用和依赖。香烟中尼古丁含量的显着降低代表 创新的监管策略有可能显着减少消费并带来更大的 戒烟的可能性。 《家庭吸烟预防和烟草控制法案》(FSPTCA) 使 FDA 制定烟草产品标准，包括限制卷烟中允许的尼古丁含量。 为了安全、成功地实施这样的政策，必须解决一些关键问题 进行评估。一个主要问题是确定每支香烟的尼古丁含量适当低 低于尼古丁的成瘾“阈值”，同时平衡减少的戒断效应 并最大限度地提高可接受性。研究 1 直接涉及这个问题。研究 1 将评估三种不同的低 6 周内的尼古丁产量（0.02、0.06、0.18 毫克），生成的数据将用于选择 项目 1 的剩余研究以及项目 2 和 3 的最佳尼古丁产量。第二个主要问题是 同时尼古丁替代疗法（NRT）是否有助于向极低尼古丁过渡 含量（VLNC）香烟。最近的证据表明 NRT 可能会减少 VLNC 香烟的使用， 减少每支烟吸入的烟雾量，降低戒烟率。研究 2 将比较 VLNC 香烟对参与者中 21 毫克透皮尼古丁的影响对另一组吸烟者的影响 佩戴安慰剂贴片时吸 VLNC 香烟。第三组吸正常尼古丁含量的香烟 佩戴安慰剂贴片将作为额外的控制措施。 相关性（参见说明）： 该项目有两个目标。研究 1 将确定极低尼古丁香烟的最佳产量，从而导致 减少吸烟，同时也最大限度地减少不适和最大程度的可接受性。研究 2 将确定尼古丁是否 替代品有助于向尼古丁含量极低的香烟过渡。这两项研究都将增进对 使用尼古丁含量极低的香烟来减轻吸烟健康负担的可行性。