N/A
Completed N=240
A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
Healthy Volunteers
Source: ClinicalTrials.gov NCT04019626 ↗
Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Concentration of Carboxyhemoglobin in Blood — -59.6; -62.7; -46.4; -62.7 % change from baseline
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Carboxyhemoglobin in Blood |
-59.6; -62.7; -46.4; -62.7; 8.5 | — |
| PRIMARY Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours |
-58.3; -44.7; -62.7; -70.7; 1.1 | — |
| PRIMARY Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours |
-60.0; -55.7; -50.5; -53.8; 1.6 | — |
| PRIMARY Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours |
-85.9; -44.9; -63.1; -73.8; -2.7 | — |
| SECONDARY Amount of Nicotine Equivalents in Urine in 24 Hours |
-7.8; 16.6; -13.8; -1.3; -7.0 | — |
| SECONDARY Level of White Blood Cells |
-9.2; -4.3; -8.7; -8.5; 4.7 | — |
| SECONDARY Subjective Measure: Nicotine Withdrawal Symptoms Total Score |
8.6; 5.7; 7.1; 6.8; 8.1 | — |
| SECONDARY Maximum Nicotine Concentration in Blood |
4.0; 7.3; 4.3; 8.9; 13.5; 6.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT04019626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.