F17.1
Conditions
Interventions
Group 1: Consumption of a conventional tobacco cigarette (approx. 3-20 minutes)
at predefined times over a period of about 60-75 minutes:
- a total of 8 blood samples
- Answering questionnaires (QSU,
Sponsors
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: a. Lifetime smoker (=100 cigarettes in a lifetime) b. Self-declaration as an occasional smoker (at least one cigarette within the last 30 days and at least one cigarette every 30 days as well as smoking events on a maximum of 3 days within a week) or dependent smoker according to ICD 10 and FTND or dependent smoker according to PSECD > 3 c. At least 24 hours of smoking abstinence before the start of the test d. Nicotine plasma concentration at baseline < 10ng/ml e. Normal BMI (18.5-24.9 kg/m2) f. Ability to give consent
Exclusion criteria
Exclusion criteria: a. Non-smokers b. for studies with occasional smokers: tobacco dependence according to ICD-10 / FTND>1 i. Daily cigarette consumption ii. Frequent regular consumption of other nicotine products c. In studies with occasional smokers: PSECD (Penn State Electronic Cigarette Dependence Index) > 3 d. Existing pregnancy i. For contraceptive methods with a Pearl Index > 0.9, a negative pregnancy test must be pregnancy test must be available before the start of testing e. Pre-existing psychiatric conditions i. Acute suicidal tendencies ii. Acute psychiatric illnesses according to ICD-10 iii. Drugs, medication, alcohol abuse at the time of the study f. Pre-existing internal diseases i. Acute malignant cancer ii. Malignant cancer in the last 5 years iii. Severe previous illnesses / risk factors of the cardiovascular system 1. manifest arterial hypertension 2. severe cardiac diseases (history of myocardial infarction, heart failure) 3. pacemaker 4. diabetes mellitus iv. Respiratory diseases (e.g. asthma, COPD) v. Severe active infectious diseases (hepatitis, HIV) g. CO > 5ppm in the expiratory tract h. BMI 24.9 kg/m2 i. Other circumstances which, in the opinion of the investigator, argue against participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The nicotine kinetics does not differ significantly between conventional tobacco cigarettes and menthol cigarettes, as well as tobacco cigarettes mentholated with tobacco accessories. Nicotine and its breakdown products are determined in a total of eight blood samples at predefined times (before, during and after consumption) of the product to be tested. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The smoking topography and the obstruction of the small airways do not differ significantly between conventional tobacco cigarettes and menthol cigarettes, as well as tobacco cigarettes mentholated with tobacco accessories. 2. The assessment of the products with regard to liking, craving and aversion does not differ significantly between conventional tobacco cigarettes and menthol cigarettes, as well as tobacco cigarettes mentholated with tobacco accessories. | — |
Countries
Germany
Contacts
Public ContactAndrea Rabenstein
Klinik für Psychiatrie und Psychotherapie, LMU München
Outcome results
None listed