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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019626
• Other study ID #: CA22747
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Fontem Ventures BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Continue-smoking
Ad-libitum use of subjects' usual brand combustible cigarette
• myblu Tobacco 2.5%
Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine
• myblu Tobacco 4.0%
Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine
• myblu Honeymoon 2.5%
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
• myblu Honeymoon 4.0%
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
• JUUL 5%
Ad-libitum use of JUUL 5% e-cigarette

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Fontem Ventures BV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Carboxyhemoglobin in Blood	Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood	Baseline and 56 days
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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