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临床试验/DRKS00024751
DRKS00024751招募中不适用

sage behavior and nicotine kinetics during ad libitum use of tobacco heating systems, e-cigarettes, and tobacco cigarettes - Nicotide 2

MU Klinikum München - Klinik für Psychiatrie und Psychotherapie0 个研究点目标入组 45 人开始时间: 2022年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
45

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 55 Years(—)
性别
All

入选标准

  • Other general inclusion criteria:
  • - 12-hour abstinence.
  • - CO < 5ppm; measurement in expiratory air using micro-smokerlyzer (Bedfont Scientific Ltd).
  • - Nicotine plasma concentration at baseline < 10 ng/ml.
  • - Capacity to agree to an informed consent.
  • Special inclusion criteria for electric cigarette users:
  • - experienced user of e-cigarettes with pod system (JUUL, myblu) for >3 months, daily use
  • - No daily use of conventional tobacco cigarettes for >3 months.
  • Special inclusion criteria for IQOS users:
  • - experienced IQOS user for > 3 months, daily consumption of at least 10 heets of tobacco sticks
  • - no daily use of conventional tobacco cigarettes for > 3 months
  • Special inclusion criteria for smokers:
  • - smoker for > 5 years
  • - consumption of > 10 cigarettes/day

排除标准

  • Exclusion criteria
  • - patients under 18 years of age or over 55 years of age
  • - acute psychiatric illness according to ICD-10/DSM IV
  • - other severe psychiatric illnesses
  • - acute suicidal tendencies
  • - existing pregnancy
  • - drug, medication or alcohol abuse at the time of the study
  • - current malignant cancer during the last 5 years
  • - severe internal diseases, especially cardiovascular diseases, such as
  • manifest arterial hypertension, severe heart disease (DCM, history of myocardial infarction), cardiac pacemaker
  • - respiratory diseases (e.g. asthma, COPD)
  • - severe active infectious diseases
  • - CO >5 ppm in expirium
  • - Nicotine plasma concentration at baseline >10 ng/ml
  • - no capacity to agree to an informed consent
  • - Other circumstances that, in the opinion of the responsible study physician, militate against the patient's participation in this study.

研究者

发起方
MU Klinikum München - Klinik für Psychiatrie und Psychotherapie

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