The E-cigarette Fagerström Test of Cigarette Dependence or Penn State Electronic Cigarette Dependence Index
Conditions
Interventions
Group 1: The intervention group consists of about 40 young, healthy volunteers who use disposable e-cigarettes no less than 6 times a week. An important criterion is a lifetime consumption of <100 con
Sponsors
LMU Klinikum München -- Klinik für Psychatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 29 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target criteria are, - Lung function, determined with the spirometer (single measurement) and with Tremoflo before the test phase, after completion and after a 30-minute break. The Tiffeneau index, airway resistance and lung reactance are determined. - Cardiovascular parameters such as blood pressure, heart rate and vascular stiffness are measured at minute 0, 5, 16, 30 and 60. - Smoking topography is recorded by a sensor throughout the session, starting with the first puff and ending after 30 minutes and with the last puff, respectively. - The questionnaires on side effects and the mCEQ before the start of the vapour period. - Dependence of the subjects will be determined by the Penn State Electronic Cigarette Dependence Index and The E-cigarette Fagerström Test of Cigarette Dependence. Primarily, the change in lung function due to lifetime use will be assessed by spirometry, and the short-term and acute effects of vaping will be assessed by Tremoflo. The values will then be compared with literature values of healthy adults of the same age who do not vapourise. | — |
Secondary
| Measure | Time frame |
|---|---|
| The nicotine kinetics in the acute phase, as well as in the course of the session, compared to occasional smokers. The smoking topography of the test persons is also to be compared with occasional smokers. For this purpose, the study "Studies on new nicotine innovation products", DRKS registration number: 00030978 will be used. The change in cardiovascular parameters and side effects will also be assessed. | — |
Countries
Germany
Contacts
Public ContactAndrea Rabenstein
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed