Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects
研究概览
简要总结
A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).
详细描述
A placebo-controlled study that will enroll male and female tobacco smokers' menthol to participate in five experimental sessions. During the experimental session, subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). The infusion conditions for each experimental session will be determined in random order. Aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. Data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products. Presented is the time frame at which the peak change was strongest by treatment arm. The possible peak numbers could be 1, 3, 5, 7 and 10 minutes."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant will not know nicotine dose or rate of infusion.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
nicotine saline infusion 0.00mcg/kg/s
0.00 mcg/kg/s The day order will be randomized per day
干预措施: Nicotine saline infusion 0.00mcg/kg/s (Drug)
nicotine infusion 0.24mcg/kg/s
0.24mcg/kg/s The day order will be randomized per day
干预措施: Nicotine infusion 0.24mcg/kg/s (Drug)
nicotine infusion 0.096mcg/kg/s
0.096mcg/kg/s The day order will be randomized per day
干预措施: Nicotine infusion 0.096mcg/kg/s (Drug)
nicotine infusion 0.048mcg/kg/s
0.048mcg/kg/s The day order will be randomized per day
干预措施: Nicotine infusion 0.048 mcg/kg/s (Drug)
nicotine infusion 0.024mcg/kg/s
0.048mcg/kg/s The day order will be randomized per day
干预措施: Nicotine infusion 0.024mcg/kg/s (Drug)
结局指标
主要结局
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects
时间窗: up to 10 minutes post infusion
The peak change in the intensity of subjective effects as measured by the DEQ: Drug pleasurable effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects
时间窗: up to 10 minutes
The peak change in the intensity of subjective effects as measured by the DEQ: Drug stimulatory effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.
次要结局
未报告次要终点
研究者
Mehmet Sofuoglu
Professor of Psychiatry
Yale University