Investigations on nicotine innovation products.

MU Klinikum München - Klinik für Psychiatrie und Psychotherapie0 个研究点目标入组 18 人开始时间: 2023年2月21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 29 years of age
•b. Lifetime smoker (=100 cigarettes in a lifetime).
•c. Self-declaration as occasional smoker (at least one cigarette within the
•past 30 days and at least one cigarette every 30 days, as well as smoking events on 3 days or less within a week)
•d. At least 12 hours of smoking abstinence prior to the start of the test.
•e. Nicotine plasma concentration to baseline < 10ng/ml.
•f. Capacity to consent

•a.Subjects under 18 or over 29 years of age
•b.Non-smokers
•c. tobacco dependence according to ICD-10 / FTND>1
•i.Daily cigarette consumption
•ii.Frequent regular use of other nicotine products
•d. PSECDI (Penn State Electronic Cigarette Dependence Index) > 3
•e.Existing pregnancy
•i.For contraceptive methods with Pearl Index > 0.9, a negative pregnancy test must be available prior to initiation of testing
•f.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
•g.Pre-existing internal medical conditions
•i.Acute malignant cancer
•ii.Malignant cancer in the past 5 years
•iii.Severe pre-existing conditions/risk factors of the cardiovascular system.
•1. manifest arterial hypertension
•2. severe cardiac history (history of myocardial infarction, heart failure)
•3. cardiac pacemaker
•4. diabetes mellitus
•iv.Respiratory disease (such as asthma, COPD).
•v.Severe active infectious diseases (hepatitis, HIV).
•h.CO > 5ppm in the expiratory fluid
•i.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