Very Low-Nicotine Cigarettes in Smokers with SUD: Smoking, Substance Use Effects

描述(由申请人提供)：2009年通过的《家庭吸烟预防和烟草控制法案》(FSPTCA)赋予食品和药物管理局(FDA)在符合公共健康的情况下降低香烟中尼古丁水平的权力。本项目致力于 这是美国国立卫生研究院和美国食品和药物管理局研究的一个领域，目的是评估毒性降低的产品对烟草使用行为的影响。一些对普通人群吸烟者进行的研究表明，与很少或没有补偿性吸烟的戒烟相比，极低尼古丁含量香烟(VLNCC)可以减少对烟草的渴望和戒烟，这表明强制降低香烟的尼古丁产量可以大幅降低吸烟率。这可能是在烟草依赖率非常高的特殊人群中减少吸烟和吸烟相关疾病的特别有效的方法，例如患有物质使用障碍(SUD)的人。然而，这项政策对患有SUD的吸烟者的影响还没有调查，已经呼吁对这些脆弱人群的这些产品的安全性进行研究。这项研究的目的是确定VLNCC在患有SUD(当前或过去一年)的吸烟者中的有效性、可接受性和意外后果。主要目的是确定VLNCC是否会增加戒烟并减少吸烟，相对于基线和随机分配到正常尼古丁含量香烟(NNCC)的吸烟者，VLNCC是否会减少吸烟、可替宁和毒性生物标记物，并确定VLNCC对物质使用和对使用物质的渴望的任何意外影响，从而调查安全性。第二个目标是研究对香烟渴望、尼古丁戒断和依赖的影响(机制)，以及状态抑郁(安全性)。两组组间的前置设计将比较6周的VLNCC和NNCC；所有吸烟者也将得到吸烟咨询。6个月以上的随访将评估恢复正常吸烟后的效果。重要的是从对高度成瘾人群中吸烟和其他物质使用的影响方面确定这一公共健康战略的可行性和安全性，这是在FDA实施这一政策之前确定的关键。

DESCRIPTION (provided by applicant): The 2009 passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the Food and Drug Administration (FDA) the authority to reduce levels of nicotine in cigarettes if appropriate for public health. This project addresses an area targeted for study by NIH and the FDA to assess the impact of products with reduced toxicity on tobacco use behaviors. Very-low nicotine content cigarettes (VLNCC) have been shown in some studies with smokers from the general population to reduce craving and withdrawal for tobacco relative to abstinence with little or no compensatory smoking, suggesting that a mandated reduction in the nicotine yield of cigarettes could substantially reduce smoking rates. This may be a particularly effective method of reducing smoking and smoking-related disease in special populations that have very high rates of tobacco dependence, such as people with substance use disorders (SUD). However, the consequences of this policy for smokers with SUD have not been investigated, and a call has gone out for studies of the safety of these products with vulnerable populations such as these. The purpose of this study is to determine the efficacy, acceptability and unintended consequences of VLNCC in smokers with SUD (current or past year). The primary aims are to determine whether VLNCC will increase smoking cessation and reduce cigarette use, cotinine, and biomarkers of toxicity in smokers with SUD relative to baseline and to those randomized to a normal nicotine content cigarette (NNCC), and to determine any unintended effects of VLNCC on substance use and cravings to use substances so as to investigate safety. Secondary aims are to study effects on cigarette craving and nicotine withdrawal and dependence (mechanisms), and state depression (safety). A 2-group between-group by pre-post design will compare 6 weeks of VLNCC to NNCC; all smokers will also be provided with smoking counseling. Follow-up over 6 months will assess effects after return to usual cigarettes. The importance is in determining the viability and safety of this publi health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.