Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine
研究概览
简要总结
This is a pilot study of the effects of dermal melanin on dermal uptake and retention of nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with lower uptake and longer retention of nicotine in the skin and body.
详细描述
This is an interventional pharmacokinetic study comparing the uptake and metabolism of nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and people with high levels of dermal melanin. The study will measure nicotine and metabolites of nicotine in the blood during exposure and in urine for 10 days after exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Smoke exposure is impossible to mask and team is too small to mask data analysis until later stages.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult nonsmoker
- •Aged 18-50
- •Skin reflectance scores below 150 or above 249 using the Mexameter 18 instrument
- •Healthy on the basis of medical history
- •Systolic blood pressure <150
- •Diastolic blood pressure <100
- •C-reactive protein <3.1 mg/ml
- •Liver function (AST and ALT) in normal ranges
- •kidney function (BUN) in normal ranges
- •Blood glucose <110
- •Not exposed to tobacco SHS.
排除标准
- •Dermal skin reflectance score between 150 and 249, as measured by the Mexameter 18 instrument.
- •Positive SARS-CoV-2 antibody test
- •Age 18 < or > 50
- •Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.
- •Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications
- •Systolic blood pressure greater than or equal to 150
- •Diastolic blood pressure greater than or equal to 100
- •Blood glucose greater than or equal to 110
- •LDL greater than or equal to130
- •Pregnancy or breastfeeding (by urine hCG and/or history)
- •Alcohol or illicit drug dependence within the past 5 years
- •BMI > 35 and < 18
- •Current illicit drug use (by history or urine test)
- •More than 1 pack year smoking history
- •Ever a daily marijuana smoker
- •Smoked anything within the last 3 months
- •Unable to hold allergy or other OTC medicines
- •Occupational exposure to smoke, dusts OR fumes
- •Concurrent participation in another clinical trial
- •Unable to communicate in English
- •No social security number
研究组 & 干预措施
High melanin
Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument
干预措施: Wear clothing that has been exposed to cigarette smoke for 3 hours. (Other)
Low melanin
Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument.
干预措施: Wear clothing that has been exposed to cigarette smoke for 3 hours. (Other)
结局指标
主要结局
Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine
时间窗: First void, collected for 10 days
The study will measure urinary metabolites of nicotine in the first void of the day for 10 days after exposure and sum the total mass of metabolites.
Change in blood concentrations of nicotine
时间窗: Baseline and 3 hours
The study will measure concentration of nicotine in the blood before and after the dermal exposure to nicotine.
次要结局
- Urinary concentration of the NNK metabolite NNAL(First void, collected for 10 days)