A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

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 combustible cigarettes to the myblu e-cigarette, for up to 56 days. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers. Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.

Key facts

Study ID

NCT04019626

Run by

Fontem Ventures BV

People needed

240

Starts

2019-03-01

Expected to finish

2020-12-31

Last updated by the study team

2021-06-30

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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