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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Continue-smoking; Other: myblu Tobacco 2.5%; Other: myblu Tobacco 4.0%; Other: myblu Honeymoon 2.5%; Other: myblu Honeymoon 4.0%; Other: JUUL 5%

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continue-smoking; The subject's usual brand of combustible cigarette	Other: Continue-smoking; Ad-libitum use of subjects' usual brand combustible cigarette
Experimental: 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.	Other: myblu Tobacco 2.5%; Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine
Experimental: 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.	Other: myblu Tobacco 4.0%; Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine
Experimental: 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.	Other: myblu Honeymoon 2.5%; Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
Experimental: 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.	Other: myblu Honeymoon 4.0%; Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
Active Comparator: JUUL 5%; JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study.	Other: JUUL 5%; Ad-libitum use of JUUL 5% e-cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Carboxyhemoglobin in Blood	Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood	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	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	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	Baseline and 56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	56 days
Maximum Nicotine Concentration in Blood	The maximum nicotine concentration in blood (Cmax)	5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose

Collaborators and Investigators

• Sponsor: Fontem Ventures BV

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CA22747

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No