Skip to main content
OpenTrials
Completed

NCT Number: NCT04019626

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continue-smoking

Other

Ad-libitum use of subjects' usual brand combustible cigarette

myblu Tobacco 2.5%

Other

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

myblu Tobacco 4.0%

Other

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

myblu Honeymoon 2.5%

Other

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

myblu Honeymoon 4.0%

Other

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

JUUL 5%

Other

Ad-libitum use of JUUL 5% e-cigarette

Primary outcomes

  1. Concentration of Carboxyhemoglobin in Blood

    Time frame: Baseline and 56 days

    Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood

  2. Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours

    Time frame: Baseline and 56 days

    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

  3. Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours

    Time frame: Baseline and 56 days

    Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours

  4. Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours

    Time frame: Baseline and 56 days

    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

Secondary outcomes

  1. Amount of Nicotine Equivalents in Urine in 24 Hours

    Time frame: Baseline and 56 days

    The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours

  2. Level of White Blood Cells

    Time frame: Baseline and 56 days

    The change from baseline in the level of white blood cells, which is a biomarker of potential harm

  3. Subjective Measure: Nicotine Withdrawal Symptoms Total Score

    Time frame: 56 days

    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.

  4. Maximum Nicotine Concentration in Blood

    Time frame: 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose

    The maximum nicotine concentration in blood (Cmax)

Sponsors and collaborators

Lead sponsor

Fontem Ventures BV

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.