Initial Cross-over Test of a Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine in Smokers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Harm exposure - Lung function
研究概览
简要总结
A novel heat-not-burn tobacco product (IQOS) will be provided to smokers, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. This study will examine the short-term effects of IQOS, switching from combustible to noncombustible nicotine and withdrawal-related symptoms over a two week-long "practice" period, relative to smoking as usual.
详细描述
The current within-subjects crossover study aims to directly compare initial efficacy of IQOS vs (cigarette) smoking as usual on switching from tobacco cigarettes during two-week "practice" periods in smokers.
Study interventions include IQOS, a commercially available, over the counter product. The IQOS is a commercially available tobacco product that consists of a holder which contains a rechargeable battery and an electronically heated metal blade.
All procedures will take place in the Prevention and Early Detection Center (PEDC) at the UPMC Hillman Cancer Center. Participants will be assessed daily via remote CO assessment and online questionnaire throughout the entire study (WK1-WK5). At the end of a one-week baseline of normal smoking (WK1), participants will be randomized to either: 1) begin a two-week period of attempting to completely switch to exclusive IQOS use (IQOS First); or 2) continue to smoke as usual (IQOS Last; WK2-WK3), followed by a second two-week period during which they will smoke as usual or attempt to switch to IQOS (opposite of the first period; WK4-WK5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, ages 21-77
- •Current smoker with ≥5 cigarettes per day for ≥1 year history of smoking
- •Screening CO ≥8 ppm
- •Not currently interested in quitting smoking
- •Willing to briefly switch from combustible to noncombustible nicotine
- •Have reliable daily access to a smartphone or tablet compatible with the iCO Smokerlyzer app:
- •Android 8 or higher, iOS 8 or higher
- •Bluetooth-enabled device
排除标准
- •Current use of smoking cessation medications such as varenicline or bupropion
- •Major chronic medical problems, including cardiovascular disease, diabetes
- •Pregnancy (a urine pregnancy test will be administered at screening for all women of child bearing potential).
结局指标
主要结局
Harm exposure - Lung function
时间窗: Up to 5 weeks
Lung function will be assessed using standard pulmonary function test.
Harm exposure - Blood pressure
时间窗: Up to 5 weeks
Blood pressure will be assessed using a sphygmomanometer.
Objective smoke exposure
时间窗: Up to 5 weeks
Assessed daily using a mobile carbon monoxide monitor (iCO) provided to participants. Carbon monoxide (CO) readings parts per million (ppm) will be submitted directly via email using the iCO smartphone app.
Self-reported smoke exposure
时间窗: Up to 5 weeks
Assessed daily using self-reported cigarette consumption, with values submitted via online Qualtrics survey.
次要结局
- Cigarette craving(Up to 5 weeks)
- Withdrawal symptoms(Up to 5 weeks)
研究者
Jian-Min Yuan, MD
Professor
University of Pittsburgh