Studies on the use of disposable e-cigarettes and their effects on pulmonary and cardiovascular parameters in young adults.
- Conditions
- The E-cigarette Fagerström Test of Cigarette Dependence or Penn State Electronic Cigarette Dependence Index
- Registration Number
- DRKS00032823
- Lead Sponsor
- MU Klinikum München -- Klinik für Psychatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method