Smoking topography, nicotine kinetics and subjective smoking experience with menthol-containing HTP products of the IQOS brand

Not Applicable

Recruiting

Conditions: F17.2

Registration Number: DRKS00028817

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: 15

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

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

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 with use of mentholated HTP compared with nonmentholated HTP and conventional smoking tobacco.

Secondary Outcome Measures

Name	Time	Method
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.