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

Fontem Ventures

Status: Completed

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04019626

CA22747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 6 patient groups

Continue-smoking

Active Comparator group

Description:

The subject's usual brand of combustible cigarette

Treatment:

Other: Continue-smoking

myblu Tobacco 2.5%

Experimental group

Description:

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.

Treatment:

Other: myblu Tobacco 2.5%

myblu Tobacco 4.0%

Experimental group

Description:

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.

Treatment:

Other: myblu Tobacco 4.0%

myblu Honeymoon 2.5%

Experimental group

Description:

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.

Treatment:

Other: myblu Honeymoon 2.5%

myblu Honeymoon 4.0%

Experimental group

Description:

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.

Treatment:

Other: myblu Honeymoon 4.0%

JUUL 5%

Active Comparator group

Description:

JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study.

Treatment:

Other: JUUL 5%