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

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ClinicalTrials.gov Identifier: NCT04019626
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Fontem Ventures BV

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. 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 sub-study.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Continue-smoking Other: myblu Tobacco Chill 2.5% Other: myblu Tobacco Chill 4.0% Other: myblu Honeymoon 2.5% Other: myblu Honeymoon 4.0% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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 Chill 2.5%
myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 2.5% nicotine
Other: myblu Tobacco Chill 2.5%
Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 2.5% nicotine

Experimental: myblu Tobacco Chill 4.0%
myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 4.0% nicotine
Other: myblu Tobacco Chill 4.0%
Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 4.0% nicotine

Experimental: myblu Honeymoon 2.5%
myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 2.5% nicotine
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 Intense Liquidpod, 4.0% nicotine
Other: myblu Honeymoon 4.0%
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine




Primary Outcome Measures :
  1. Concentration of carboxyhemoglobin in blood [ Time Frame: 56 days ]
    Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood

  2. Amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol in urine in 24 hours [ Time Frame: 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: 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: 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 Outcome Measures :
  1. Amount of nicotine in urine in 24 hours [ Time Frame: 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: 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 [ 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: 180 minutes following the start of product use (11 measurements over the period) ]
    The maximum nicotine concentration in blood (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019626


Contacts
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Contact: Julie Saathoff +1 402 437 4829 julie.saathoff@celerion.com

Locations
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United States, Nebraska
Celerion Recruiting
Lincoln, Nebraska, United States, 68502
Contact: Julie Saathoff    402-437-4829    julie.saathoff@celerion.com   
Sponsors and Collaborators
Fontem Ventures BV

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Responsible Party: Fontem Ventures BV
ClinicalTrials.gov Identifier: NCT04019626     History of Changes
Other Study ID Numbers: CA22747
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action