Investigations on nicotine innovation products.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 18

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.