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

Primary Purpose

Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
JUUL Virginia Tobacco flavored 5.0% ENDS
PMI iQOS Heat sticks
Reynolds VUSE Solo ENDS - Original
Imperial MyBlu ENDS - Original
Altria MarkTen ENDS - Bold Classic
MLV PHIX ENDS - Original Tobacco
NJOY Daily EXTRA ENDS - Rich Tobacco
Altria Marlboro combustible cigarette - Red
Sponsored by
Juul Labs, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nicotine Dependence focused on measuring Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Christchurch Clinical Studies Trust Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

JUUL Virginia Tobacco flavored 5.0% ENDS

PMI iQOS Heat sticks

Reynolds VUSE Solo ENDS - Original

Imperial MyBlu ENDS - Original

Altria MarkTen ENDS - Bold Classic

MLV PHIX ENDS - Original Tobacco

NJOY Daily EXTRA ENDS - Rich Tobacco

Altria Marlboro combustible cigarette - Red

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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.
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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.
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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

Measure exhaled Carbon Monoxide change in all product administration periods
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
Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
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.
Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
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.

Full Information

First Posted
September 18, 2018
Last Updated
June 10, 2021
Sponsor
Juul Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03700112
Brief Title
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
February 24, 2019 (Actual)
Study Completion Date
April 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juul Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
Keywords
Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JUUL Virginia Tobacco flavored 5.0% ENDS
Arm Type
Experimental
Arm Description
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
Arm Title
PMI iQOS Heat sticks
Arm Type
Experimental
Arm Description
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
Arm Title
Reynolds VUSE Solo ENDS - Original
Arm Type
Experimental
Arm Description
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
Arm Title
Imperial MyBlu ENDS - Original
Arm Type
Experimental
Arm Description
Administration of Imperial MyBlu ENDS - Original consumed using 10 puffs delivery method Administration of Imperial MyBlu ENDS - Original consumed using ad-libitum delivery method
Arm Title
Altria MarkTen ENDS - Bold Classic
Arm Type
Experimental
Arm Description
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
Arm Title
MLV PHIX ENDS - Original Tobacco
Arm Type
Experimental
Arm Description
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
Arm Title
NJOY Daily EXTRA ENDS - Rich Tobacco
Arm Type
Experimental
Arm Description
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
Arm Title
Altria Marlboro combustible cigarette - Red
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
JUUL Virginia Tobacco flavored 5.0% ENDS
Intervention Description
Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
Intervention Type
Other
Intervention Name(s)
PMI iQOS Heat sticks
Intervention Description
PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
Intervention Type
Other
Intervention Name(s)
Reynolds VUSE Solo ENDS - Original
Intervention Description
Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
Intervention Type
Other
Intervention Name(s)
Imperial MyBlu ENDS - Original
Intervention Description
Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
Intervention Type
Other
Intervention Name(s)
Altria MarkTen ENDS - Bold Classic
Intervention Description
Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
Intervention Type
Other
Intervention Name(s)
MLV PHIX ENDS - Original Tobacco
Intervention Description
MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
Intervention Type
Other
Intervention Name(s)
NJOY Daily EXTRA ENDS - Rich Tobacco
Intervention Description
NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
Intervention Type
Other
Intervention Name(s)
Altria Marlboro combustible cigarette - Red
Intervention Description
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
Primary Outcome Measure Information:
Title
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Description
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.
Time Frame
48 days
Title
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Description
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)
Time Frame
48 days
Title
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Description
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.
Time Frame
48 days
Title
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Description
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)
Time Frame
48 days
Title
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Description
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
Time Frame
48 days
Secondary Outcome Measure Information:
Title
Measure exhaled Carbon Monoxide change in all product administration periods
Description
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
Time Frame
48 days
Title
Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
Description
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.
Time Frame
48 days
Title
Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
Description
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.
Time Frame
48 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Concetta Carbonaro
Organizational Affiliation
JUUL
Official's Role
Study Director
Facility Information:
Facility Name
Christchurch Clinical Studies Trust Ltd
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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