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OpenTrials
Completed

NCT Number: NCT03700112

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christchurch Clinical Studies Trust Ltd

Christchurch, 8011, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female aged 18 to 60 years of age inclusive.
  • BMI between 18 to 35 kg / m2 inclusive.
  • Healthy based on medical history and screening assessments, in the opinion of the Investigator.
  • Current smoker of at least 8 cigarettes per day on average.
  • 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.
  • Able to participate, and willing to give written informed consent and comply with study restrictions.

Exclusion criteria

  • Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
  • Clinically significant abnormality on screening ECG.
  • 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.
  • Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
  • 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.
  • Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
  • Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day 1.
  • Blood or plasma donation of > 500 mL within 1 month prior to Assessment Day 1.
  • Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
  • 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.

Treatment and study plan

JUUL Virginia Tobacco flavored 5.0% ENDS

Other

Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum

PMI iQOS Heat sticks

Other

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

Reynolds VUSE Solo ENDS - Original

Other

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

Imperial MyBlu ENDS - Original

Other

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

Altria MarkTen ENDS - Bold Classic

Other

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

MLV PHIX ENDS - Original Tobacco

Other

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

NJOY Daily EXTRA ENDS - Rich Tobacco

Other

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

Altria Marlboro combustible cigarette - Red

Other

Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Juul Labs, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Jun 14, 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.

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