DRKS00026244已完成未知
Systemic nicotine uptake and side effect by all-white nicotine pouches - Nicotide Pouches
MU Klinikum München - Klinik für Psychiatrie und Psychotherapie0 个研究点目标入组 26 人开始时间: 2022年8月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •smoker for >5 years, consumption of >10 cigarettes/day.
- •12-hour abstinence (nicotine and tobacco).
- •CO <5 ppm; measured in expiratory air using micro-smokerlyzer (Bedfont Scientific Ltd).
- •nicotine plasma concentration at baseline <10 ng/ml.
- •capacity to consent
排除标准
- •subjects <18 or >55 years of age
- •use of other nicotine products >1x/week (e.g., nicotine pouches, snus, e-cigarette)
- •use of certain medications in the past 14 days that interact with nicotine via CYP enzymes
- •acute psychiatric illness or other serious psychiatric illnesses according to ICD-10/DSM IV
- •acute suicidal tendencies
- •existing pregnancy or current breastfeeding
- •drug, medication, or alcohol abuse at the time of the study
- •current or less than 5 years past malignant disease
- •severe internal diseases, especially cardiovascular diseases such as manifest arterial hypertension, severe heart disease (DCM, history of myocardial infarction), pacemaker or respiratory insufficiency (e.g. bronchial asthma, COPD)
- •severe active infectious diseases
- •CO >5ppm in expiratory air
- •other circumstances which, in the opinion of the investigator, militate against the subject's participation in this study
研究者
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