Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Heart rate will be used to see the dose effect
研究概览
简要总结
To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.
详细描述
Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The main outcome measures will be self-report drug effects and urges to smoke cigarettes.
The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate.
This study is complete with 13 enrolled and 10 completers
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
- •Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year
- •smoke ≥ 5 and less than 20 cigarettes per day
- •urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker
- •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; and 6) 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
- •use of e-cigarettes more than 10 days in the past 30 days
- •urine drug screening indicating recent illicit drugs use (with the exception of marijuana)
研究组 & 干预措施
nicotine infusion 0.2mg
nicotine infusion
0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) The day order will be randomized over 5 days.
干预措施: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s (Drug)
nicotine infusion 2.0mg
0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries),
干预措施: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s (Drug)
nicotine infusion 1.0mg
1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries)
干预措施: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s (Drug)
nicotine infuison 1.0mg
1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).
干预措施: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s (Drug)
Saline
saline delivered over 2minutes ,2.5minutes,10 minutes
干预措施: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s (Drug)
结局指标
主要结局
Heart rate will be used to see the dose effect
时间窗: During nicotine infusion max of ten minutes
the dose-effect curves of nicotine dose and delivery rate in heart rate
次要结局
未报告次要终点
研究者
Mehmet Sofuoglu
Professor of Psychiatry
Yale University