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

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

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 including cardiovascular parameters when consuming novel tobacco products based on rooibos (glo veo Scarlet Click) compared to conventional tobacco cigarettes and tobacco sticks.

Secondary Outcome Measures

Name	Time	Method
Assessment of nicotine kinetics in the acute phase, as well as changes in cytokine response and biomarkers when consuming novel tobacco products based on rooibos (glo veo Scarlet Click) compared to conventional tobacco cigarettes and tobacco sticks.