Effects of Menthol in E-cigarettes on Smoking Behaviors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Plasma nicotine levels
研究概览
简要总结
The overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 21 years of age
- •Able to read and write English.
- •Smoking at least 1 menthol cigarettes/cigars/little cigars per day
- •Report regular menthol cigarette use
- •Have at least 200ng/ml urine cotinine
- •Willing to abstain from combustible tobacco products 12 hrs prior to each experimental session.
- •not planning a smoking quit attempt.
- •Have not stopped use due to COVID.
- •used e-cigarettes at least 10 times in the past six months.
- •Fully vaccinated against COVID-
- •must report history of JUUL and other nicotine salt/pod devices (i.e., JUUL-like)
排除标准
- •Use of psychoactive drugs including anxiolytics, antidepressants, and other psychostimulants unless prescribed and stable for two months.
- •Current diagnosis of any severe psychiatric disorder
- •Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, pulmonary or hepatic pathology that would increase risk or would interfere with/mimic tobacco abstinence.
- •Known hypersensitivity to propylene glycol and nut allergies.
- •Pregnant or lactating females.
- •current criteria for moderate or severe cannabis and alcohol use disorder per DSM-5 criteria.
- •current criteria for other substance use disorders per DSM-5 criteria.
- •Seeking treatment to stop smoking.
- •individuals who do not want to use e-cigarettes.
- •Uncontrolled asthma (defined as <20 on Asthma Control Test) AND/OR endorsement of "yes" to environmentally induced bronchospasm that requires prescription Epipen)
- •blood pressure >170/>100 and heart rate >100
- •vaping of CBD/THC or marijuana related products in the past 3 months
- •For current THC vapers: Any report of mild or great EVALI-related symptoms (i.e. cough, shortness of breath, chest pain, nausea, vomiting, stomach pain, diarrhea, fever, chills, or weight loss) without non-EVALI reasonable and proximal cause
研究组 & 干预措施
5% nicotine with menthol flavor and tobacco flavor
All participants will receive 5% nicotine/menthol and 5% nicotine/tobacco e-cigarettes over the course of 2 lab sessions; the order of which flavor goes first at each lab session is counterbalanced with half getting menthol flavor first and half getting tobacco flavor first.
干预措施: Nicotine (Drug)
结局指标
主要结局
Plasma nicotine levels
时间窗: up to 3 weeks
blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure
Nicotine Metabolic Rate
时间窗: up to 3 weeks
blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure
Plasma Nicotine Levels
时间窗: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.
Mean plasma levels obtained after e-cigarette administration at each lab session (lab 1 and lab 2).
Nicotine Metabolic Rate
时间窗: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.
Mean Area under the curve (AUC) for plasma nicotine and NMR were computed and then log transformed to reduce skewness of the two measures.
次要结局
未报告次要终点