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临床试验/DRKS00032823
DRKS00032823招募中Unknown

Studies on the use of disposable e-cigarettes and their effects on pulmonary and cardiovascular parameters in young adults.

MU Klinikum München -- Klinik für Psychatrie und Psychotherapie0 个研究点目标入组 40 人开始时间: 2024年4月19日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
40

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
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 29 Years(—)
性别
All

入选标准

  • 1. at least 12 hours of nicotine abstinence before the start of the test.
  • 2. nicotine plasma concentration at baseline < 10ng/ml
  • 3. ability to give consent
  • 4. use of disposables for at least 3 mo., with current use at least 6d/week
  • 5. self-declaration as regular e-cigarette user of nicotine-containing products

排除标准

  • 1. non-vaporiser or
  • 2. lifetime smoker = 100 cigarettes and/or tobacco-containing joints in a lifetime.
  • 3. tobacco use in the last 30 days
  • 4. dual-use in the last 30 days, when consuming inhaled products
  • 5. lifetime hookah sessions are limited to a maximum of 5, with no session in the last six months
  • 6. tobacco dependence according to ICD-10 / FTND > 1 or PSECD > 3
  • 6.1 Daily cigarette consumption
  • 6.2. frequent regular use of other nicotine products
  • 7. existing pregnancy
  • 7.1. for contraceptive methods with Pearl index > 0.9, a negative pregnancy test must be available before testing begins
  • 8. pre-existing psychiatric conditions
  • 8.1 Acute suicidal tendencies
  • 8.2 Acute psychiatric illnesses according to ICD-10
  • 8.3. drugs, medication, alcohol abuse at the time of the study
  • 9. previous internal diseases
  • 9.1 Acute malignant cancer
  • 9.2. malignant cancer in the last 5 years
  • 9.3. severe previous illnesses / risk factors of the cardiovascular system
  • 9.3.1. manifest arterial hypertension
  • 9.3.2. severe previous cardiac disease (history of myocardial infarction, heart failure)
  • 9.3.3. pacemaker
  • 9.3.4. diabetes mellitus
  • 9.4. respiratory diseases (such as asthma, COPD)
  • 9.5. severe active infectious diseases (hepatitis, HIV)
  • 10. CO > 5ppm in the expiratory fluid
  • 11. other circumstances which, in the opinion of the investigator, militate against participation in the study

研究者

发起方
MU Klinikum München -- Klinik für Psychatrie und Psychotherapie

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