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Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.

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ClinicalTrials.gov Identifier: NCT03700112
Recruitment Status : Enrolling by invitation
First Posted : October 9, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Juul Labs, Inc.

Brief Summary:
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers

Condition or disease Intervention/treatment Phase
Nicotine Dependence Nicotine Dependence, Cigarettes Tobacco Use Tobacco Smoking Device: JUUL Virginia Tobacco flavored 5.0% ENDS Device: PMI iQOS Heat sticks Device: Reynolds VUSE Solo ENDS - Original Device: Imperial MyBlu ENDS - Original Device: Altria MarkTen ENDS - Bold Classic Device: MLV PHIX ENDS - Original Tobacco Device: NJOY Daily EXTRA ENDS - Rich Tobacco Device: Altria Marlboro combustible cigarette - Red Not Applicable

Detailed Description:
E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 Puff and Ad-libitum) Conditions, in Healthy Adult Smokers.
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : February 24, 2019
Estimated Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: JUUL Virginia Tobacco flavored 5.0% ENDS

Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed using 10 puffs delivery method

Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed Ad-libitum delivery method

Device: JUUL Virginia Tobacco flavored 5.0% ENDS
Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum

Experimental: PMI iQOS Heat sticks

Administration of PMI iQOS Heat sticks - Regular consumed using 10 puffs delivery method

Administration of PMI iQOS Heat sticks - Regular consumed ad-libitum delivery method

Device: PMI iQOS Heat sticks
PMI IQOS Heat sticks is administered using a controlled method and ad-libitum

Experimental: Reynolds VUSE Solo ENDS - Original

Administration of Reynolds VUSE Solo ENDS - Original consumed using 10 puffs delivery method

Administration of Reynolds VUSE Solo ENDS - Original consumed using ad-libitum delivery method

Device: Reynolds VUSE Solo ENDS - Original
Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum

Experimental: Imperial MyBlu ENDS - Original

Administration of Imperial MyBlu ENDS - Original consumed using 10 puffs delivery method

Administration of Imperial MyBlu ENDS - Original consumed using ad-libitum delivery method

Device: Imperial MyBlu ENDS - Original
Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum

Experimental: Altria MarkTen ENDS - Bold Classic

Administration of Altria MarkTen ENDS - Bold Classic consuming using 10 puffs delivery method

Administration of Altria MarkTen ENDS - Bold Classic consuming using ad-libitum delivery method

Device: Altria MarkTen ENDS - Bold Classic
Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum

Experimental: MLV PHIX ENDS - Original Tobacco

Administration of MLV PHIX ENDS - Original Tobacco consumed using 10 puffs delivery method

Administration of with MLV PHIX ENDS - Original Tobacco consumed using ad-libitum delivery method

Device: MLV PHIX ENDS - Original Tobacco
MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum

Experimental: NJOY Daily EXTRA ENDS - Rich Tobacco

Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using 10 puffs delivery method

Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using delivery method and ad-libitum

Device: NJOY Daily EXTRA ENDS - Rich Tobacco
NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum

Experimental: Altria Marlboro combustible cigarette - Red
Administration of Altria Marlboro combustible cigarette - Red consumed using 10 puffs delivery method Administration of Altria Marlboro combustible cigarette - Red consumed using ad-libitum delivery method
Device: Altria Marlboro combustible cigarette - Red
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum




Primary Outcome Measures :
  1. Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. [ Time Frame: 48 days ]
    To estimate nicotine pharmacokinetics (PK) profiles across 8 E-Cigarette/cigarette products within-each and between-all delivery conditions (10 puffs versus ad libitum puffs) using Area Under the nicotine concentration-time curve (AUC1hour) calculated using linear trapezoidal summation from time zero (defined as the start of product use) to 60 minutes.

  2. Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. [ Time Frame: 48 days ]
    Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)

  3. Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. [ Time Frame: 48 days ]
    Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax (Maximum measured plasma concentration over the duration of the measurement interval.

  4. Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. [ Time Frame: 48 days ]
    Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)

  5. Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. [ Time Frame: 48 days ]
    Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Tmax(Time of the maximum measured plasma concentration over the duration of the measurement interval. If the maximum value occurs at more than one time point within the time span specified, Tmax is defined as the first time point with this value


Secondary Outcome Measures :
  1. Measure exhaled Carbon Monoxide change in all product administration periods [ Time Frame: 48 days ]
    To estimate change in exhaled carbon monoxide (CO) for 8 E-cigarettes/cigarettes Products, in all product administration periods under 2 different delivery (10 puff and ad-libitum) conditions. Exhaled CO will be measured 5-15 minutes prior to initiation of the first inhalation, and up to 15 minutes after the collection of the 30 minute PK sample

  2. Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale [ Time Frame: 48 days ]

    To characterize measures of subjective effects with use of 8 E-cigarettes/cigarettes Products under 2 different delivery (10 puff and ad-libitum) conditions using a modified Product Evaluations Scale questionnaire using scale below after collection of the 30-minute PK sample and exhaled CO measurement.

    Change in Evaluation: 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, 7= extremely

    Four multi- item subscales will be derived from "Satisfaction" (questions 1, 2, 3, and 12); "Psychological Reward" (questions 4 through 8); "Aversion" (questions 9, 10, 16, and 18) and "Relief" (questions 11, 13, 14, 15, and reversed for question 19) and single questions 17 and 20 will be summarized.


  3. Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette [ Time Frame: 48 days ]
    To characterize consumptions of 8 E-cigarettes/cigarettes products within-each and between-all delivery conditions (10 puffs versus ad-libitum puffs), by collecting total number of puffs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female aged 18 to 60 years of age inclusive.
  2. BMI between 18 to 35 kg / m2 inclusive.
  3. Healthy based on medical history and screening assessments, in the opinion of the Investigator.
  4. Current smoker of at least 8 cigarettes per day on average.
  5. Has been smoking for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator.
  6. Able to participate, and willing to give written informed consent and comply with study restrictions.

Exclusion Criteria:

  1. Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
  2. Clinically significant abnormality on screening ECG.
  3. Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
  4. Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
  5. Positive result for urine drugs of abuse test or alcohol breath test at screening. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test.
  6. Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
  7. Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day 1.
  8. Blood or plasma donation of > 500 mL within 1 month prior to Assessment Day 1.
  9. Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
  10. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

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): NCT03700112


Locations
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New Zealand
Christchurch Clinical Studies Trust Ltd
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Juul Labs, Inc.
Investigators
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Study Director: Concetta Carbonaro JUUL

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Responsible Party: Juul Labs, Inc.
ClinicalTrials.gov Identifier: NCT03700112     History of Changes
Other Study ID Numbers: PROT-00013
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juul Labs, Inc.:
Electronic Nicotine Delivery System
Combustible Cigarettes
Nicotine

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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