F17.2
Conditions
Interventions
Group 1: Intervention group 1/3: mentholated Heated Tobacco Products of the brand "IQOS Heets Torquoise":
Here, according to the study protocol, a CO measurement of the expirium is performed before t
Sponsors
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: a. Respondent between 18 and 55 years of age b. Lifetime smoker (=100 cigarettes in a lifetime). c. Self-declared occasional smoker (at least one cigarette within the past 30 days and at least one cigarette every 30 days) d. At least 12 hours of smoking abstinence before 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 55 years of age b. Tobacco dependence according to ICD-10 / FTND>1 i. Daily cigarette consumption ii. Frequent regular use of other nicotine products c. Existing pregnancy i. For contraceptive methods with Pearl index > 0.9, a negative SST must be present prior to initiation of testing d. 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 e. Pre-existing internal medical conditions i. Respiratory insufficiency (e.g., asthma, COPD). ii. Malignant cancer in the past 5 years iii. Severe pre-existing cardiovascular disease and risk factors. 1. manifest arterial hypertension 2. history of myocardial infarction 3. heart failure 4. diabetes mellitus iv. Severe active infectious diseases (Hepatitis. HIV). f. CO > 5ppm in the expirium g. 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 with use of mentholated HTP compared with nonmentholated HTP and conventional smoking tobacco. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of nicotine kinetics in the acute phase, as well as changes in cardiovascular parameters during the consumption of mentholated HTP compared to non-mentholated HTP and conventional smoking tobacco. | — |
Countries
Germany
Contacts
Public ContactAndrea Rabenstein
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed