A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes
An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers
1 other identifier
interventional
39
1 country
1
Brief Summary
This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers. Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy-volunteers
Started Dec 2019
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedFirst Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedResults Posted
Study results publicly available
June 7, 2021
CompletedJune 7, 2021
May 1, 2021
2 months
June 10, 2020
April 14, 2021
May 11, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Maximum Nicotine Concentration in Blood
Maximum nicotine concentration in blood (Cmax)
180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)
Concentration of Carboxyhemoglobin in Blood
Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
Baseline and 8 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 (NNK), excreted in urine during 24 hours (creatinine adjusted).
Baseline and 8 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 during 24 hours (creatinine adjusted).
Baseline and 8 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 during 24 hours (creatinine adjusted).
Baseline and 8 days
Secondary Outcomes (4)
Level of White Blood Cells
Baseline and 8 days
Spirometry: Forced Expiratory Volume in 1 Second
Baseline and 8 days
Spirometry: Forced Vital Capacity
Baseline and 8 days
Subjective Measure: Urge to Smoke
8 days
Study Arms (8)
Product use sequence ABDC
EXPERIMENTALSubjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
Product use sequence BCAD
EXPERIMENTALSame as previous arm, but in a different randomization order.
Product use sequence CDBA
EXPERIMENTALSame as previous arm, but in a different randomization order.
Product use sequence DACB
EXPERIMENTALSame as previous arm, but in a different randomization order.
Product use sequence EFHG
EXPERIMENTALSubjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
Product use sequence FGEH
EXPERIMENTALSame as previous arm, but in a different randomization order.
Product use sequence GHFE
EXPERIMENTALSame as previous arm, but in a different randomization order.
Product use sequence HEGF
EXPERIMENTALSame as previous arm, but in a different randomization order.
Interventions
Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine
Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine
Use of Myblu e-cigarette with flavor C at 2.4% nicotine
Use of Myblu e-cigarette with flavor D at 2.4% nicotine
Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine
Fse of Myblu e-cigarette with flavor F at 1.2% nicotine
Use of Myblu e-cigarette with flavor G at 2.4% nicotine
Use of Myblu e-cigarette with flavor H at 2.4% nicotine
Eligibility Criteria
You may qualify if:
- smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
- tested positive for urine cotinine (≥ 200 ng/mL) at Screening
- exhaled carbon monoxide \> 10 ppm (parts per million) at Screening
You may not qualify if:
- relevant illness history
- relevant medication use
- body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening
- allergy to propylene glycol or glycerin
- use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
- use of any prescription smoking cessation treatments within 3 months prior to Check-in
- smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
- planning to quit smoking during the study
- female subjects who are pregnant, lactating, or intend to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fontem US LLClead
- Fontem Ventures BVcollaborator
Study Sites (1)
Celerion
Lincoln, Nebraska, 68502, United States
Related Publications (1)
Morris P, McDermott S, Chapman F, Verron T, Cahours X, Stevenson M, Thompson J, Chaudhary N, O'Connell G. Reductions in biomarkers of exposure to selected harmful and potentially harmful constituents following exclusive and partial switching from combustible cigarettes to myblu electronic nicotine delivery systems (ENDS). Intern Emerg Med. 2022 Mar;17(2):397-410. doi: 10.1007/s11739-021-02813-w. Epub 2021 Aug 26.
PMID: 34435305DERIVED
Results Point of Contact
- Title
- Paul Morris
- Organization
- Nerudia Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
December 1, 2019
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
June 7, 2021
Results First Posted
June 7, 2021
Record last verified: 2021-05