Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 638
- 试验地点
- 2
- 主要终点
- E-cig Use at End of Sampling Period
研究概览
简要总结
The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.
详细描述
Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •current smoker
- •regular use of email OR capacity to receive SMS text and internet access
- •additional smoking and health criteria determined at screening
排除标准
- 未提供
结局指标
主要结局
E-cig Use at End of Sampling Period
时间窗: at week 4
percentage of participants reporting using an e-cigarette
次要结局
- Conversion(Study enrollment through end of 6-month follow up)
- Smoking Cessation(at 6-month follow-up)
研究者
Matthew Carpenter
Professor
Medical University of South Carolina