An interventional study of Use of nicotine product (smoking/vaping) in Nicotine Dependence, Vaping and Smoking, sponsored by University Hospital Muenster. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-27.
Sponsored by University Hospital Muenster · Not applicable, Interventional, and Basic science
The survey participants are divided into a smoking and non-smoking group. The smoker group is further divided according to the quantity and quality of nicotine ("normal" smoking, vaping). After reaching a steady state, the cutaneous blood flow at rest in the extremities of all participants is determined by Laser Doppler Imaging as a reference value. Laser Doppler Imaging produces images of the blood flow using perfusion units (PU). Subsequently, the perfusion is measured again after smoking/vaping. The difference in skin perfusion of the extremities is calculated (δ-Perfusion). All measurements are performed under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the patients.
After consenting to the study, the subjects are examined using Laser Doppler Camera.
The skin blood flow of the extremities is determined as a reference value. Laser Doppler Imaging produces images of the blood flow using the perfusion units (PU).
All measurements are taken under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the subjects.
For smokers or vapers, the perfusion is measured again after consuming a cigarette or an e-cigarette respectively. The difference of blood flow after smoking or vaping is calculated using both measures.
The total duration of the study per subject is approximately 25-30 minutes.
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 198 is above the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.
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Healthy adult non-smokers, smokers, vapers
Exclusion Criteria:
Healthy subjects who do not consume any nicotine products
Healthy subjects who consume nicotine products
Behavioral: Use of nicotine product (smoking/vaping)
The smokers/vapers are consuming during the study one nicotine product of their own. The dose is the same as each individual is consuming regularly
Perfusion of the extremities for non-smokers, smokers and vapers
The perfusion of the extremities will be measured in Perfusion Units. The Perfusion Units are calculated directly through the Laser Doppler Camera as a result of the examination.
Time frame: 30 seconds
Difference of perfusion after smoking/vaping
The perfusion of the extremities will be measured after the consume of cigarettes/electronic cigarettes in Perfusion Units. The difference between the results of the examination before and after the consume of cigarettes/electronic cigarettes will be measured in Perfusion Units.
Time frame: 30 seconds
Correlation of perfusion with age
The age (years) will be controlled as a possible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the age in years of each subject.
Time frame: 30 seconds
Correlation of perfusion with gender
The gender(male or female) will be controlled as a possible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the gender of each subject.
Time frame: 30 seconds
Correlation of perfusion with quantity of smoking/vaping
The quantity of smoking/vaping (packet years/nicotine quantity for vaping) will be controlled as apossible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the quantity of smoking of each related subject.
Time frame: 30 seconds
Plan to share: No
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University Hospital Muenster