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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Amount of Nicotine Equivalents in Urine in 24 Hours(Baseline and 56 days)
- Level of White Blood Cells(Baseline and 56 days)
- Subjective Measure: Nicotine Withdrawal Symptoms Total Score(56 days)
- 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)