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

NCT04019626 | Completed Results

• 1 other identifier: CA22747
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (6)

Continue-smoking

ACTIVE COMPARATOR

The subject's usual brand of combustible cigarette

Other: Continue-smoking

myblu Tobacco 2.5%

EXPERIMENTAL

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%

myblu Tobacco 4.0%

EXPERIMENTAL

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%

myblu Honeymoon 2.5%

EXPERIMENTAL

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%

myblu Honeymoon 4.0%

EXPERIMENTAL

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%

JUUL 5%

ACTIVE COMPARATOR

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

Other: JUUL 5%

Interventions

Continue-smoking OTHER

Ad-libitum use of subjects' usual brand combustible cigarette

Continue-smoking

myblu Tobacco 2.5% OTHER

Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine

myblu Tobacco 2.5%

myblu Tobacco 4.0% OTHER

Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine

myblu Tobacco 4.0%

myblu Honeymoon 2.5% OTHER

Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine

myblu Honeymoon 2.5%

myblu Honeymoon 4.0% OTHER

Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine

myblu Honeymoon 4.0%

JUUL 5% OTHER

Ad-libitum use of JUUL 5% e-cigarette

JUUL 5%

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fontem Ventures BV: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Results Point of Contact

• Title: Paul Morris
• Organization: Nerudia Ltd

paul.morris@nerudia.com

+44 7508 708 917

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 15, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Locations

US (1)