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临床试验/NCT04646668
NCT04646668已完成不适用

Comparative Abuse Liability of Cigarettes, E-cigarettes, and Heat-not-burn Devices Among African American and White Smokers

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年9月21日最近更新:
适应症
干预措施

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.

Active Comparator

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

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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