此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

CSD170202: A Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

2017年9月7日 更新者:RAI Services Company

CSD170202: A Crossover Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

This study will evaluate exposure to tobacco constituents from two moist snuff products, and provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of each of the two moist snuff products.

研究概览

地位

完全的

条件

详细说明

This will be an unblinded, single-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). Enrolled subjects will use one of each of the study products exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, with a different product used each week over a two-week period. During each test visit, subjects will use study product ad libitum during a 6-hour period. Expectoration will be collected from the subjects during each product use. The used study product will be collected after use. Blood samples will be collected at each test visit, prior to study product use, for determination of plasma cotinine levels.

研究类型

介入性

注册 (实际的)

55

阶段

  • 不适用

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

    • Georgia
      • Stockbridge、Georgia、美国、30281
        • Clinical Research Atlanta

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

21年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;
  2. Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit;
  3. Self-reports currently using at least two cans of moist snuff per week;
  4. Self-reports that moist snuff is the only tobacco- or nicotine-containing product used within 30 days of the Screening-Enrollment Visit;
  5. Usual brand (UB) of moist snuff is one of the products specified in the protocol;
  6. Used their UB product for ≥ 3 months;
  7. Subject is not delaying a decision to quit using moist snuff to participate in the study;
  8. Agrees to exclusively use the study products and not use any other tobacco- or nicotine-containing products during the course of the study;
  9. Able to safely perform the required study procedures, as determined by the Investigator.

Exclusion Criteria:

  1. Self-reported history of heart disease, kidney disease, diabetes, liver disease, uncontrolled hypertension, or uncontrolled hypercholesterolemia;
  2. At risk for heart disease, i.e., obesity (body mass index [BMI] > 43 kg/m2), as determined by the Investigator;
  3. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
  4. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening-Enrollment Visit;
  5. Females who are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
  6. Participation in another clinical study within 30 days prior to the Screening-Enrollment Visit. (The 30-day window for each subject will be derived from the date of the last study event in the previous study to the Screening-Enrollment Visit of the current study);
  7. Determined by the Investigator to be ineligible for the study.

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

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:CSD170202AA, CSD170202AB Use Group
Use of product CSD170202AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170202AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit.
A moist snuff product
A moist snuff product
实验性的:CSD170202AB, CSD170202AA Use Group
Use of product CSD170202AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170202AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit.
A moist snuff product
A moist snuff product

研究衡量的是什么?

主要结果指标

结果测量
大体时间
每克(或产品)尼古丁的口腔水平暴露量 (MLE)
大体时间:6个小时
6个小时

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:Nathan Segall, MD、Clinical Research Atlanta

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 (实际的)

2017年5月8日

初级完成 (实际的)

2017年7月25日

研究完成 (实际的)

2017年7月25日

研究注册日期

首次提交

2017年5月16日

首先提交符合 QC 标准的

2017年5月16日

首次发布 (实际的)

2017年5月18日

研究记录更新

最后更新发布 (实际的)

2017年9月8日

上次提交的符合 QC 标准的更新

2017年9月7日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • CSD170202

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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.

订阅