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

Not Applicable

Completed

Interventions: Other: Continue-smoking
Other: myblu Honeymoon 4.0%
Other: myblu Honeymoon 2.5%
Other: JUUL 5%
Other: myblu Tobacco 2.5%
Other: myblu Tobacco 4.0%

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Continue-smoking	Continue-smoking	The subject's usual brand of combustible cigarette
myblu Honeymoon 4.0%	myblu Honeymoon 4.0%	myblu e-cigarette system with Honeymoon flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
myblu Honeymoon 2.5%	myblu Honeymoon 2.5%	myblu e-cigarette system with Honeymoon flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
JUUL 5%	JUUL 5%	JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study.
myblu Tobacco 2.5%	myblu Tobacco 2.5%	myblu e-cigarette system with Tobacco flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
myblu Tobacco 4.0%	myblu Tobacco 4.0%	myblu e-cigarette system with Tobacco flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.

Primary Outcome Measures

Name	Time	Method
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours	Baseline and 56 days	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
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours	Baseline and 56 days	Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours
Concentration of Carboxyhemoglobin in Blood	Baseline and 56 days	Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours	Baseline and 56 days	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

Secondary Outcome Measures

Name	Time	Method
Amount of Nicotine Equivalents in Urine in 24 Hours	Baseline and 56 days	The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
Level of White Blood Cells	Baseline and 56 days	The change from baseline in the level of white blood cells, which is a biomarker of potential harm
Subjective Measure: Nicotine Withdrawal Symptoms Total Score	56 days	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.
Maximum Nicotine Concentration in Blood	5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose	The maximum nicotine concentration in blood (Cmax)