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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
240
Ad-libitum use of subjects' usual brand combustible cigarette
Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine
Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine
Celerion
Lincoln, Nebraska, United States
Concentration of Carboxyhemoglobin in Blood
Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
Time frame: Baseline and 56 days
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL - a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) excreted in urine in 24-hours
Time frame: Baseline and 56 days
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours
Time frame: Baseline and 56 days
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA - a biomarker of exposure to benzene) excreted in urine in 24-hours
Time frame: Baseline and 56 days
Amount of Nicotine Equivalents in Urine in 24 Hours
The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
Time frame: Baseline and 56 days
Level of White Blood Cells
The change from baseline in the level of white blood cells, which is a biomarker of potential harm
Time frame: Baseline and 56 days
Subjective Measure: Nicotine Withdrawal Symptoms Total Score
Nicotine withdrawal symptoms are measured using the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) questionnaire. The DSM-5 and craving items from the MTWS-R have been included. The subjects rate themselves on the questionnaire, which includes symptoms such as angry, irritable, frustrated, depressed mood, restless, insomnia. Each question is rated from 0 (none) to 4 (severe). Total scores may range from 0 to a maximum of 32.
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Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
Ad-libitum use of JUUL 5% e-cigarette
Time frame: 56 days
Maximum Nicotine Concentration in Blood
The maximum nicotine concentration in blood (Cmax)
Time frame: 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose