Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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.
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.
Secondary ID [1] 0 0
PROT-00013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nicotine Dependence 0 0
Nicotine Dependence, Cigarettes 0 0
Tobacco Use 0 0
Tobacco Smoking 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Timepoint [1] 0 0
48 days
Primary outcome [2] 0 0
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Timepoint [2] 0 0
48 days
Primary outcome [3] 0 0
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Timepoint [3] 0 0
48 days
Primary outcome [4] 0 0
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Timepoint [4] 0 0
48 days
Primary outcome [5] 0 0
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Timepoint [5] 0 0
48 days
Secondary outcome [1] 0 0
Measure exhaled Carbon Monoxide change in all product administration periods
Timepoint [1] 0 0
48 days
Secondary outcome [2] 0 0
Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
Timepoint [2] 0 0
48 days
Secondary outcome [3] 0 0
Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
Timepoint [3] 0 0
48 days

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2019
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Juul Labs, Inc.
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT03700112
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Concetta Carbonaro
Address 0 0
JUUL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03700112