Comparative Abuse Liability of Cigarettes, E-cigarettes, and Heat-not-burn Devices Among African American and White Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Nicotine Delivery
研究概览
简要总结
The study is a randomized crossover trial. Current smokers will complete a session with each product: usual brand cigarette, e-cigarette, and heat-not-burn. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring.
详细描述
The study is a randomized crossover trial. Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). Throughout each visit, blood will be collected for nicotine analysis via an IV catheter placed in the patient's arm. Blood samples will be aliquoted into two separate vials. One will be analyzed for the current study and one will be placed in a biospecimen repository if participant provides consent for biorepository. Puff topography will be collected passively throughout the session to measure puffing patterns. Participants will complete self-report measures of nicotine withdrawal and craving. Finally, breath samples will be collected to measure changes in exhaled carbon monoxide, a potent lung toxicant, pre- and post-product use. At the final visit, participants will complete a behavioral economics concurrent choice task (see below for description) to behaviorally measure their decisions regarding use of e-cigarettes or heat not burn products in place of cigarettes. Finally, participants will be contacted by phone 6 months following the conclusion of visit 3 (or study discontinuation) to complete a phone survey. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring. We have no hypotheses related to the follow-up.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Hispanic African American or white/Caucasian,
- •≥21 years old, smoke 5-30 cigarettes per day,
- •daily cigarette smoker
- •smoked at current rate for at least 6 months
- •interested in trying e-cigarettes and heat not burn products
- •not interested in or unable/unwilling to quit cigarette smoking
- •willing to complete three in-person study visits
- •willing to have IV catheter placed
排除标准
- •Interested in quitting cigarettes in the next 30 days
- •use of smoking cessation pharmacotherapy in the past 30 days
- •use of non-cigarette tobacco products in the past 30 days
- •use of e-cigarettes >5x in lifetime
- •use of e-cigarettes ≥4 of the past 30 days
- •use of heat not burn products >5x in lifetime
- •use of heat not burn products ≥4 of the past 30 days
- •weight < 110 lbs
- •uncontrolled hypertension (systolic BP ≥ 180 or diastolic BP ≥ 105)
- •pregnant, plans to become pregnant, or breastfeeding
- •live >10 miles from study site (Fairway CRU)
- •current enrollment is a research study or program that aims to alter tobacco use
研究组 & 干预措施
E-Cigarette then Heat not burn.
We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device.
干预措施: E-cigarette and Heat not burn (Combination Product)
Heat not burn then E-Cigarette
We will use a 1:1 fashion randomization to product order combustible cigarette, heat-not-burn device, e-cigarette.
干预措施: E-cigarette and Heat not burn (Combination Product)
结局指标
主要结局
Nicotine Delivery
时间窗: Baseline, after 10 puff bout of product at 5 minutes
Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes
次要结局
未报告次要终点
