F 17.2
Conditions
Interventions
Group 1: Intervention group 1/4: Elf Bar 600 Strawberry Kiwi:
Here, according to the study protocol, a CO measurement of the expirium is performed before the start of the test. This is followed by a
Sponsors
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 29 Years
Inclusion criteria
Inclusion criteria: a. Respondent between 18 and 29 years of age b. Lifetime smoker (=100 cigarettes in a lifetime). c. Self-declaration as occasional smoker (at least one cigarette within the past 30 days and at least one cigarette every 30 days, as well as smoking events on 3 days or less within a week) d. At least 12 hours of smoking abstinence prior to the start of the test. e. Nicotine plasma concentration to baseline < 10ng/ml. f. Capacity to consent
Exclusion criteria
Exclusion criteria: a. Subjects under 18 or over 29 years of age b. Non-smokers c. tobacco dependence according to ICD-10 / FTND>1 i. Daily cigarette consumption ii. Frequent regular use of other nicotine products d. PSECDI (Penn State Electronic Cigarette Dependence Index) > 3 e. Existing pregnancy i. For contraceptive methods with Pearl Index > 0.9, a negative pregnancy test must be available prior to initiation of testing f. Pre-existing psychiatric conditions i. Acute suicidality ii. Acute psychiatric illness as defined by ICD-10. iii. Drug, medication, alcohol abuse at the time of the study g. Pre-existing internal medical conditions i. Acute malignant cancer ii. Malignant cancer in the past 5 years iii. Severe pre-existing conditions/risk factors of the cardiovascular system. 1. manifest arterial hypertension 2. severe cardiac history (history of myocardial infarction, heart failure) 3. cardiac pacemaker 4. diabetes mellitus iv. Respiratory disease (such as asthma, COPD). v. Severe active infectious diseases (hepatitis, HIV). h. CO > 5ppm in the expiratory fluid i. Other circumstances that, in the opinion of the investigator, militate against participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of changes in smoking behavior, subjective smoking experience and side effects when consuming new tobacco products (Elf Bar 600) compared to smoking conventional tobacco and myblu. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of nicotine kinetics in the acute phase and changes in cardiovascular parameters when consuming new tobacco products (Elf Bar 600) compared to smoking conventional tobacco and myblu. | — |
Countries
Germany
Contacts
Public ContactAndrea Rabenstein
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed