IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Drug Effects Questionnaire mean score
研究概览
简要总结
This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.
详细描述
Seventy smokers will be randomized to nicotine doses of either 0.2 or 1 mg per 70 kg body weight. Across 5 test sessions, within each dose group, participants will be randomly assigned to a sequence of 5 treatment conditions: placebo (saline) and 4 different delivery rates of nicotine. In each session, participants will receive either nicotine- or saline-pulsed infusions that will be delivered every 30 seconds for a total of 10 pulsed infusions. While receiving the pulsed infusions, participants will inhale a tobacco-flavored EC without nicotine, which will allow for a closer matching of the sensory aspects of inhaled tobacco use. There are four pulse duration conditions for the nicotine sessions: 2-, 4-, 6- and 8-second pulses. For those assigned to 1.0 mg/70kg nicotine dose, the pulse duration conditions correspond to nicotine delivery rates of 50, 25, 16.6, and 12.5 mcg nicotine/second. For those assigned to 0.2 mg/70 kg dose, the corresponding delivery rates will be 10, 5, 3.3 and 2.5 mcg nicotine/second. Participants in both nicotine dose groups will each have one placebo test session wherein they will receive 10 pulsed-saline infusions.
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)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male, aged 21 to 55 years;
- •past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests
- •women, -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 participant to be in the study
- •risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD
- •regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- •current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine
- •for women, pregnant as determined by pregnancy screening, or breast feeding
- •seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.
研究组 & 干预措施
delivery rate for nicotine dose 1mg/70kg
delivery rate 50,35, 16.6 and 12.5 ug per second
干预措施: low dose Nicotine (Drug)
Delivery rate for nicotine dose 0.2mg/70kg
delivery rate 10,5, 3.3 and 2.5
干预措施: high dose Nicotine (Drug)
结局指标
主要结局
Drug Effects Questionnaire mean score
时间窗: up to five years
The DEQ measures Good Drug Effect and consists of 11 questions with total score range from 0-100. Higher scores indicate more positive effects.
次要结局
未报告次要终点
研究者
Mehmet Sofuoglu
Professor of Psychiatry
Yale University