The Effect of Nicotine Delivery Rate on Reinforcement
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Peak Change on items of the Drug Effects Questionnaire (DEQ)
研究概览
简要总结
The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.
详细描述
A placebo-controlled study that will recruit male and female nicotine dependent smokers/EC users (n=18) to complete four separate experimental sessions. Each session will include one randomly assigned infusion that will be either saline or a single dose of nicotine (1 mg per 70 kg body weight) delivered at three different infusion rates, rapid, moderate or slow (0.24, 0.048 or 0.024 mcg per kg body weight per second). A total infusion duration of 10 min will be maintained during each session by adding saline infusions of variable duration after nicotine delivery. This will be achieved by two separate infusion pumps, one for saline and one for nicotine. For example, the rapid 0.24 mcg/kg/s condition will include a 1 min infusion of nicotine followed by a 9 min infusion of saline. The subjects will be blinded to the infusion pump procedures. The rapid delivery rate, which we have used in our prior studies, induces positive subjective drug effects and suppresses symptoms of nicotine withdrawal. The moderate delivery rate,0.048 mcg/kg/s, approximates the rate of nicotine intake encountered while smoking a typical cigarette over 5 min (4). The slowest nicotine delivery rate, 0.024mcg/kg/s, was chosen to approximate the rate of nicotine intake encountered while using a newer EC (5).
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
- Double (Participant, Investigator)
盲法说明
Participant and Investigator will not know nicotine dose or rate of infusion.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male smokers that smoke ≥ 5 cigarettes per day for the past year
- •aged 18 to 30 years
- •urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker (23)
- •not seeking treatment at the time of the study for nicotine dependence
- •in good health as verified by medical history, screening examination, and screening laboratory tests
- •for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
排除标准
- •history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
- •regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- •current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
- •urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
研究组 & 干预措施
saline 0.00mcg/kg/s
0.00 mcg/kg/s The day order will be randomized per day
干预措施: Nicotine saline 0.00mcg/kg/s (Drug)
0.24mcg/kg/s
0.24 mcg/kg/s The day order will be randomized per day
干预措施: Nicotine 0.24 mcg/kg/s (Drug)
0.048mcg/kg/s
0.048 mcg/kg/s The day order will be randomized per day
干预措施: Nicotine 0.048 mcg/kg/s (Drug)
0.024 mcg/kg/s
0.024 mcg/kg/s The day order will be randomized per day
干预措施: Nicotine 0.024 mcg/kg/s (Drug)
结局指标
主要结局
Peak Change on items of the Drug Effects Questionnaire (DEQ)
时间窗: up to 60 minutes post infusion
The peak change in the intensity of subjective effects as measured by the DEQ
次要结局
未报告次要终点
研究者
Mehmet Sofuoglu
The effect of nicotine delivery rate on reinforcement
Yale University