NCT06442384终止不适用
Fully Remote Randomized Controlled Trial Exploring the Role of Non-combustible Tobacco Products in the Context of a Nicotine Product Standard for Cigarettes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Percent of participants that drop-out by 4 week visit
研究概览
简要总结
The goal of this pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. no restriction on e-cigarettes in smokers switched to very low nicotine content cigarettes.
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
- •Self-report of daily smoking of at least 5 to 25 cigarettes for >3 months by self-report.
- •Carbon monoxide indicative of regular smoking (CO > 6ppm) prior to randomization.
- •Has regular access to a smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys and to take photos of receipts.
- •Lives in an area where VLN® cigarettes are being marketed (these locations may vary during the course of the study).
排除标准
- •Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free <5 years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 14 days or as determined by the licensed medical professional at each site).
- •Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional).
- •Excessive drinking or problems with drinking or drugs-including marijuana (assessed by PI or licensed medical professional).
- •Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy.
- •Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact patient safety to be determined by the licensed medical professional).
- •Recent experience with VLNC cigarettes (purchasing of the VLNC cigarettes in the past year)
- •Household member enrolled in the study concurrently.
- •Participated in prior research study during the past three months that would impact baseline smoking or response to study products.
- •Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions.
- •Unstable living environment that would compromise the ability to sequester study products or complete study procedures.
研究组 & 干预措施
VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes
Experimental
Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention
干预措施: Tobacco and non-tobacco e-cigarettes (Other)
VLNC cigarettes plus access to only tobacco flavored e-cigarettes
Experimental
Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention
干预措施: Tobacco only e-cigarettes (Other)
结局指标
主要结局
Percent of participants that drop-out by 4 week visit
时间窗: 4 weeks
Percent of participants that drop-out by 4 week visit
次要结局
- Change in mean cigarettes per day (CPD)(Baseline to 4 weeks)
- Number of participants experiencing smoke free days(4 weeks)
研究者
研究点 (1)
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