Effects of Nicotine Salt Aerosol on Cigarette Smokers
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
- Plasma Nicotine
研究概览
简要总结
This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.
详细描述
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine "salt" (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be:
- •healthy (determined by self-report)
- •between 21-55 years old
- •wiling to provide informed consent
- •able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol
- •cigarette smokers
排除标准
- •Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening
- •Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
研究组 & 干预措施
Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine salt (protonated) (Other)
Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine (unprotonated) (Other)
Own brand cigarette first, then ENDS with protonated nicotine, then ENDS with unprotonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Own brand cigarette (Other)
ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine salt (protonated) (Other)
ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine (unprotonated) (Other)
ENDS with unprotonated nicotine first, then ENDS with protonated nicotine, then Own brand cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Own brand cigarette (Other)
ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine salt (protonated) (Other)
ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine (unprotonated) (Other)
ENDS with protonated nicotine first, then Own brand cigarette, then ENDS with unprotonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Own brand cigarette (Other)
ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine salt (protonated) (Other)
ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine (unprotonated) (Other)
ENDS with protonated nicotine first, then ENDS with unprotonated nicotine, then Own brand cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Own brand cigarette (Other)
Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine salt (protonated) (Other)
Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine (unprotonated) (Other)
Own brand cigarette first, then ENDS with unprotonated nicotine, then ENDS with protonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Own brand cigarette (Other)
ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine salt (protonated) (Other)
ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Subox Mini C with Avail 18 mg nicotine (unprotonated) (Other)
ENDS with unprotonated nicotine first, then Own brand cigarette, then ENDS with protonated nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
干预措施: Own brand cigarette (Other)
结局指标
主要结局
Plasma Nicotine
时间窗: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Change in plasma nicotine level
次要结局
未报告次要终点
研究者
Paul T. Harrell
Associate Professor
Eastern Virginia Medical School