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E-Cigarette and Cigarette Nicotine Delivery and Abuse Liability in Cigarette Smokers and Dual Users

2020年12月16日 更新者:University of Oklahoma

Investigation of Electronic Cigarette and Cigarette Nicotine Delivery and Abuse Liability in Cigarette Smokers and Dual Users

The FDA has shown clear interest in strategies that will reduce the public health burden of tobacco use. One proposed strategy includes banning the sale of fully nicotinized cigarettes and only allowing VLNCs (Very Low Nicotine Cigarettes) to be sold. While there are concerns regarding the unintended consequences (e.g., black market sales of fully nicotinized cigarettes) of such bans, research is needed to understand how smokers and dual users will act in the potential market. The overall aim of the current research is to understand purchasing and product choice behaviors of tobacco/nicotine users if the proposed ban were to go into effect.

研究概览

地位

撤销

条件

详细说明

Tobacco use continues to be the leading cause of preventable death in the US, with the majority of deaths due to combustible tobacco use. Electronic cigarettes (e-cigarettes) may represent a nicotine delivery device that addresses cravings and nicotine withdrawal and is much less harmful compared to cigarettes, particularly if completely substituted for cigarettes. The Food and Drug Administration (FDA) recently set forth plans that include the possibility of regulating the level of nicotine in combustible cigarettes to make them non-addictive and disallowing the sale of fully nicotinized cigarettes. While studies have shown that lowering the level of nicotine in cigarettes leads to high quit rates and would likely have a positive overall public health impact, there are concerns that doing so will lead to a black market for purchasing fully nicotinized cigarettes. However, no empirical evidence currently exists regarding this possible unintended consequence of the proposed regulation and the current project aims to fill this gap. Current smokers and dual cigarette and e-cigarette users will complete three in-lab study visits. Following screening and practice with all study products, participants will complete standardized 10-puff bouts for three e-cigarettes, the VLNCs (Very Low Nicotine Cigarettes), and their usual brand cigarette. They will then complete three concurrent choice tasks. The tasks will simulate 1) the current market, in which e-cigarettes and fully nicotinized cigarettes are available, 2) the potential future market in which e-cigarettes and VLNC (Very Low Nicotine Cigarettes) are freely available and nicotinized cigarettes are banned, and 3) the potential future market in which only tobacco flavored e-cigarettes and VLNCs (Very Low Nicotine Cigarettes) are freely available and nicotinized cigarettes are banned. Understanding, in an environment where VLNCs (Very Low Nicotine Cigarettes) are the only cigarettes available, current smokers' and dual users' product choices will fill an important gap in the research and inform regulation of these products.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • University of Oklahoma Health Sciences Center Oklahoma Tobacco Research Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

A sample of 40 current cigarette smokers (n=20) and dual e-cigarette and cigarette users (n=20) who are willing to use/try an alternative nicotine-delivery device will be recruited via advertisements/ recruitment materials (e.g., craigslist, ads on OSU, OU, and UCO campuses, OUHSC, email) and referrals. Participants will live in the Oklahoma City, OK metro area. Participants will be provided information about the study and provide initial consent for screening via an online screener.

描述

Inclusion Criteria:

  • be at least 18 years old
  • live within 30 miles of the research site
  • interested in/willing to use an e-cigarette during study visits
  • be willing and able to complete study procedures including specimen collection, survey completion, and remaining nicotine abstinent for 12 hours prior to each study visit
  • speak and understand English
  • willing to provide informed consent
  • bring usual brand cigarettes to screener study visit.

Additional Inclusion criteria for smokers:

  • smoke at least 10 cigarettes per day for the past three months,
  • exhaled more than equal to 6 ppm carbon monoxide at the screener visit.

Additional Inclusion criteria for dual users:

  • smoke more than equal to 5 tobacco cigarettes per day for the last 3 months,
  • use e-cigarettes at least 15 days per month for the last 3 months, and
  • bring e-cigarette device to screener study visit.

Exclusion Criteria:

  • currently suffering from lung disease including asthma, cystic fibrosis (CF), or chronic obstructive pulmonary disease (COPD), unless it is well-controlled,
  • currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study,
  • intoxicated at study visits (breath alcohol testing and clean urine drug screen),
  • any known allergies or sensitivity to the known major constituents contained in the aerosol of the study e-cigarette devices (e.g., flavorants, vegetable glycerin, propylene glycol),
  • User of zero-nicotine e-cigarettes,
  • smokes mentholated cigarettes regularly,
  • history of cardiac event or distress within the past 3 months.

Additional Exclusion criteria for smokers:

  • have previously used any e-cigarette device (cig-a-like, pen style, mod, APV) for longer than 30 days
  • use of an e-cigarette device over the past 14 days.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:横截面

队列和干预

团体/队列
专属香烟吸烟者
不吸烟者必须在过去三个月内每天至少吸 10 支香烟,并且在筛选访问时呼出的一氧化碳 (eCO) 水平至少为 6 ppm。
双(电子烟和吸烟)用户
电子烟和香烟双重使用者必须在过去 3 个月内每天至少吸 5 支香烟,并且在过去 3 个月内每月至少使用电子烟 15 天。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Nicotine delivery measured by serum (blood) nicotine
大体时间:1 month
Participants will complete one standardized puffing bout (10 puffs) with each of the three electronic cigarettes, usual brand cigarette and Very Low Nicotine Cigarettes (VLNCs). Serum nicotine will be measured throughout each standardized puffing bout. Greater levels of serum nicotine will be indicative of greater nicotine delivery.
1 month
在三种假设的烟草监管情景中获得和分配给每种产品的抽吸比例
大体时间:1个月
参与者将完成三项模拟假设监管场景的计算机任务,并将获得和分配粉扑以研究产品。 分配的更大比例的粉扑将表明在该假设情况下对该产品的需求更大
1个月

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Theodore Wagener, PhD、University of Oklahoma

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年6月1日

初级完成 (预期的)

2019年12月1日

研究完成 (预期的)

2019年12月1日

研究注册日期

首次提交

2019年5月7日

首先提交符合 QC 标准的

2019年5月7日

首次发布 (实际的)

2019年5月9日

研究记录更新

最后更新发布 (实际的)

2020年12月19日

上次提交的符合 QC 标准的更新

2020年12月16日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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