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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03700112
Registration number
NCT03700112
Ethics application status
Date submitted
18/09/2018
Date registered
9/10/2018
Date last updated
14/06/2021
Titles & IDs
Public title
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
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Scientific 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.
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Secondary ID [1]
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PROT-00013
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nicotine Dependence
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Nicotine Dependence, Cigarettes
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Tobacco Use
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Tobacco Smoking
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Condition category
Condition code
Mental Health
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Addiction
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - JUUL Virginia Tobacco flavored 5.0% ENDS
Other interventions - PMI iQOS Heat sticks
Other interventions - Reynolds VUSE Solo ENDS - Original
Other interventions - Imperial MyBlu ENDS - Original
Other interventions - Altria MarkTen ENDS - Bold Classic
Other interventions - MLV PHIX ENDS - Original Tobacco
Other interventions - NJOY Daily EXTRA ENDS - Rich Tobacco
Other interventions - Altria Marlboro combustible cigarette - Red
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
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
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
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
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
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
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
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
Other interventions: JUUL Virginia Tobacco flavored 5.0% ENDS
Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
Other interventions: PMI iQOS Heat sticks
PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
Other interventions: Reynolds VUSE Solo ENDS - Original
Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
Other interventions: Imperial MyBlu ENDS - Original
Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
Other interventions: Altria MarkTen ENDS - Bold Classic
Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
Other interventions: MLV PHIX ENDS - Original Tobacco
MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
Other interventions: NJOY Daily EXTRA ENDS - Rich Tobacco
NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
Other interventions: Altria Marlboro combustible cigarette - Red
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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Assessment method [1]
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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.
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Timepoint [1]
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48 days
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Primary outcome [2]
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Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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Assessment method [2]
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Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)
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Timepoint [2]
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48 days
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Primary outcome [3]
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Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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Assessment method [3]
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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.
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Timepoint [3]
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48 days
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Primary outcome [4]
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Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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Assessment method [4]
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Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)
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Timepoint [4]
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48 days
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Primary outcome [5]
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Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
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Assessment method [5]
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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
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Timepoint [5]
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48 days
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Secondary outcome [1]
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Measure exhaled Carbon Monoxide change in all product administration periods
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Assessment method [1]
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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
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Timepoint [1]
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48 days
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Secondary outcome [2]
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Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
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Assessment method [2]
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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.
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Timepoint [2]
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48 days
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Secondary outcome [3]
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Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
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Assessment method [3]
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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.
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Timepoint [3]
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48 days
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/04/2019
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Juul Labs, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT03700112
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Concetta Carbonaro
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Address
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JUUL
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03700112
Download to PDF