Biomarkers, Smoking Topography, Nicotine Kinetics, and Subjective Smoking Experience with Flavored, Nicotine-Containing HTP Products Based on Rooibos by the Brand glo - Nicotide veo

MU Klinikum München - Klinik für Psychiatrie und Psychotherapie0 个研究点目标入组 20 人开始时间: 2024年6月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•a. Participant between 18 and 55 years old
•b. Lifetime smoker (=100 cigarettes in lifetime)
•c. 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 per week) and smoker who inhales the smoke
•d. At least 24 hours of smoking abstinence before the start of testing
•e. Baseline nicotine plasma concentration < 10ng/ml
•f. Capacity to provide informed consent

•a. Participant under 18 or over 55 years of age
•b. Non-smoker
•c. Tobacco dependence according to ICD-10 / FTND = 2 / PSCDI = 3
•i. Daily cigarette consumption
•ii. Frequent regular consumption of other nicotine products
•d. Existing pregnancy
•i. For contraceptive methods with a Pearl Index > 0.9, a negative pregnancy test must be present before the start of testing
•e. Psychiatric pre-existing conditions
•i. Acute suicidality
•ii. Acute psychiatric disorders according to ICD-10
•iii. Substance abuse, medication abuse, alcohol abuse at the time of the study
•f. Internal medicine pre-existing conditions
•i. Acute malignant cancer
•ii. Malignant cancers in the last 5 years
•iii. Severe pre-existing conditions / risk factors of the cardiovascular system
•1. Manifest arterial hypertension
•2. Severe cardiac pre-existing conditions (history of heart attack, heart failure)
•3. Pacemaker
•4. Diabetes mellitus
•iv. Respiratory diseases (such as asthma, COPD)
•v. Severe active infectious diseases (hepatitis, HIV)
•g. CO > 5ppm in exhaled breath
•h. Other circumstances that, in the opinion of the investigator, speak against participation in the study

发起方

MU Klinikum München - Klinik für Psychiatrie und Psychotherapie