Status:
COMPLETED
A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
Lead Sponsor:
Fontem Ventures BV
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of co...
Detailed Description
Subjects are randomized to either continue smoking conventional cigarettes, or switch to use the myblu e-cigarette. Within the "myblu" arm, subjects were assigned to one of four variants of the myblu ...
Eligibility Criteria
Inclusion
- Having smoked ≥5 manufactured combustible cigarettes per day for at least one year
- Exhaled carbon monoxide level of \>10 ppm at screening
- Tested positive for urinary cotinine (approximately 200 ng/mL) at screening
Exclusion
- Relevant illness history
- Relevant medication use
- Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
- Allergy to propylene glycol or glycerin
- Use of nicotine-containing products other than manufactured cigarettes
- Use of prescription smoking cessation treatments
- Smokers who draw smoke into their mouth and throat but do not inhale
- Intent or desire to stop smoking
- Female subjects who are pregnant, lactating, or intend to become pregnant
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04019626
Start Date
March 1 2019
End Date
December 31 2020
Last Update
June 30 2021
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502