sage behavior and nicotine kinetics during ad libitum use of tobacco heating systems, e-cigarettes, and tobacco cigarettes
- Conditions
- F17.2
- Registration Number
- DRKS00024751
- Lead Sponsor
- MU Klinikum München - Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Other general inclusion criteria:
- 12-hour abstinence.
- CO < 5ppm; measurement in expiratory air using micro-smokerlyzer (Bedfont Scientific Ltd).
- Nicotine plasma concentration at baseline < 10 ng/ml.
- Capacity to agree to an informed consent.
Special inclusion criteria for electric cigarette users:
- experienced user of e-cigarettes with pod system (JUUL, myblu) for >3 months, daily use
- No daily use of conventional tobacco cigarettes for >3 months.
Special inclusion criteria for IQOS users:
- experienced IQOS user for > 3 months, daily consumption of at least 10 heets of tobacco sticks
- no daily use of conventional tobacco cigarettes for > 3 months
Special inclusion criteria for smokers:
- smoker for > 5 years
- consumption of > 10 cigarettes/day
Exclusion criteria
- patients under 18 years of age or over 55 years of age
- acute psychiatric illness according to ICD-10/DSM IV
- other severe psychiatric illnesses
- acute suicidal tendencies
- existing pregnancy
- drug, medication or alcohol abuse at the time of the study
- current malignant cancer during the last 5 years
- severe internal diseases, especially cardiovascular diseases, such as
manifest arterial hypertension, severe heart disease (DCM, history of myocardial infarction), cardiac pacemaker
- respiratory diseases (e.g. asthma, COPD)
- severe active infectious diseases
- CO >5 ppm in expirium
- Nicotine plasma concentration at baseline >10 ng/ml
- no capacity to agree to an informed consent
- Other circumstances that, in the opinion of the responsible study physician, militate against the patient's participation in this study.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of the study is to find out how nicotine levels differ between 4 selected nicotine products (IQOS, JUUL, Myblu, tobacco cigarette) during free use in the context of different usage behaviour. It is assumed that nicotine pharmacokinetics, use behaviour, craving and side effect profile differ between the products to be tested.
- Secondary Outcome Measures
Name Time Method In particular, the difference between predetermined usage behaviour and free usage behaviour is to be tested and put in relation to other studies.