A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers. Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.

Key facts

Study ID

NCT04430634

Run by

Fontem US LLC

People needed

40

Starts

2019-11-01

Expected to finish

2020-01-31

Last updated by the study team

2021-06-07

Who can join

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

You may qualify if…

• smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
• tested positive for urine cotinine (≥ 200 ng/mL) at Screening
• exhaled carbon monoxide > 10 ppm (parts per million) at Screening

You may not qualify if…

• relevant illness history
• relevant medication use
• body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening
• allergy to propylene glycol or glycerin
• use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
• use of any prescription smoking cessation treatments within 3 months prior to Check-in
• smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
• planning to quit smoking during the study
• 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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