F17.1
Conditions
Interventions
Group 1: 5 minutes of ad libitum consumption of 6-methyl nicotine-containing e-cigarettes. Data collection during and after consumption includes: cardiovascular parameters (minutes 0, 5, 9, 15, and 30
therefore, a 24-hour washout period exists between tests.
Group 2: 5 minutes of ad libitum consumption of nicotine-containing e-cigarettes. Data collection during and after consumption includes: cardi
therefore, a 24-hour washout period exists between tests.
Group 3: 5 minutes of ad libitum consumption of nicotine-free e-cigarettes. Data collection during and after consumption includes: cardiovascu
therefore, a 24-hour washout period exists between tests.
Sponsors
LMU
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: a. Subject between 18 and 55 years of age. b. Self-declaration as an e-cigarette user or dependent vaper according to ICD-10 and FTND. c. Smoking a maximum of 10 cigarettes per week and 3 days per week. d. At least 12 hours of smoking abstinence prior to testing. e. Baseline nicotine plasma concentration < 10 ng/ml. f. Normal BMI (18.5-24.9 kg/m²). g. Capacity to consent.
Exclusion criteria
Exclusion criteria: a. Subjects under 18 or over 55 years of age b. Non-smokers c. For studies with occasional smokers: Tobacco dependence according to ICD-10 / FTND>1 i. Daily cigarette consumption ii. Frequent regular use of other nicotine products d. For studies with occasional smokers: PSECD (Penn State Electronic Cigarette Dependence Index) > 3 e. Existing pregnancy i. For contraceptive methods with a Pearl Index > 0.9, a negative pregnancy test must be available before testing begins f. Previous psychiatric conditions i. Acute suicidality ii. Acute psychiatric conditions according to ICD-10 iii. Drug, medication, or alcohol abuse at the time of the study g. Previous medical conditions i. Acute malignant cancer ii. Malignant cancer in the last 5 years iii. Severe pre-existing conditions/cardiovascular risk factors 1. Manifest arterial hypertension 2. Severe pre-existing cardiac conditions (history of myocardial infarction, heart failure) 3. Pacemaker 4. Diabetes mellitus iv. Respiratory diseases (e.g., asthma, COPD) v. Severe active infectious diseases (hepatitis, HIV) h. BMI 24.9 kg/m2 i. Other circumstances that, in the investigator's opinion, preclude participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-Methylnicotine has similar, if not stronger, cardiovascular effects than conventional nicotine in e-cigarettes. Cardiovascular parameters: Cardiovascular parameters are assessed at each sampling time using the Mobil-O-Graph™ device (I.E.M., Stollberg, Germany) (Laurent et al., 2006; Wassertheurer et al., 2010; Weber et al., 2011). | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-Methylnicotine has similar, if not stronger, effects on the subjective smoking experience and side effects than conventional nicotine in e-cigarettes. Subjective Effects, Side Effects The subjective smoking experience is measured using the modified Cigarette Evaluation Questionnaire (mCEQ), the Questionnaire on Smoking Urgues (QSU), a subjective assessment of cravings for similar products, and "headbuses." These tests and assessments are conducted at the end of the consumption period and again 30 minutes later. The mCEQ measures the subjective effects of smoking. Participants rate 12 statements on a scale of 1-7, representing the subcategories of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, and craving reduction. Participants complete the questionnaire themselves. The mCEQ is validated in English for its dimensions (Arger et al., 2017; Cappelleri et al., 2007). No validated German translation of the mCEQ exists. For the Nicotide Accessories Study at LMU Munich, the mCEQ was translated into German independently and back-translated for quality control. This questionnaire is used to make it more accessible to our participants, and this is noted in the limitations of our study. The established QSU (Questionnaire on Smoking Urgues) questionnaire is used to assess cravings and urges to smoke. It has been translated into German (QSU-G), and its factor structure, reliability, and validity have been examined in 129 smokers. The subjective assessment of desire for other similar products will be documented using a scale of 1-7. The term "headbuss" is a colloquial term for a dim, lightheaded feeling after nicotine consumption. The subjective assessment of “Headbuss” is documented using a scale of 1-7. Side effect profile: To record side effects, participants independently complete a questionnaire on the side effect profile using a scale of 0-10. Subjectively perceived effects in the mouth/throat, salivation, | — |
Countries
Germany
Contacts
Public ContactAndrea Rabenstein
Klinik für Psychiatrie und Psychotherapie des Klinikums der Universität München
Outcome results
None listed