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

MU Klinikum München - Klinik für Psychiatrie und Psychotherapie0 个研究点目标入组 15 人开始时间: 2022年7月26日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

MU Klinikum München - Klinik für Psychiatrie und Psychotherapie