NCT06439238招募中不适用
Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- feasibility-date collection
研究概览
简要总结
This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g., nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Male or females at least 21 years of age.
- •Smoking menthol cigarettes most of the time (80% of cigarette purchases).
- •Self-report of daily smoking of at least 5 - 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 or tablet for use with CO device and smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys.
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 <= years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 30 days or as determined by the licensed medical professional at each site).
- •Purchased alternative nicotine products within the last month
- •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 at each site).
- •Excessive drinking or problems with drinking or drugs (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 biomarkers or patient safety to be determined by the licensed medical professional).
- •Vital signs outside of the following range:
- •i. Systolic BP greater than or equal to 160 ii. Diastolic BP greater than or equal to 100 iii. Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) iv. Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) v. Heart rate greater than or equal to 105 bpm vi. Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) (Participants failing for heart rate or blood pressure will be allowed to re-screen once).
- •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.
结局指标
主要结局
feasibility-date collection
时间窗: 4 weeks
Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and Interview
feasibility- drop-out rate
时间窗: 4 weeks
Percent of drop-outs by 4 week visit
次要结局
- Cigarettes smoked(baseline and week 4 visit)
- carbon monoxide change(4 weeks)
- cotinine change(4 weeks)
研究者
研究点 (2)
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