Clinical trial NCT04019626: A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
Official title: An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Fontem Ventures BV
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

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 e-cigarette, having different flavors and nicotine strengths. Initial product assignment for each subject was based on preference as a method to enhance compliance. To further improve compliance through Day 56, subjects may have been allowed to choose to switch to another variant of the myblu e-cigarette, or to continue using the same e-liquid selected initially.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Concentration of Carboxyhemoglobin in Blood
timeFrame: Baseline and 56 days
measure: Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
timeFrame: Baseline and 56 days
measure: Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
timeFrame: Baseline and 56 days
measure: Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
timeFrame: Baseline and 56 days
Secondary outcomes:
measure: Amount of Nicotine Equivalents in Urine in 24 Hours
timeFrame: Baseline and 56 days
measure: Level of White Blood Cells
timeFrame: Baseline and 56 days
measure: Subjective Measure: Nicotine Withdrawal Symptoms Total Score
timeFrame: 56 days
measure: Maximum Nicotine Concentration in Blood
timeFrame: 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References: