- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03700112
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
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 Overview
Status
Intervention / Treatment
- Other: JUUL Virginia Tobacco flavored 5.0% ENDS
- Other: PMI iQOS Heat sticks
- Other: Reynolds VUSE Solo ENDS - Original
- Other: Imperial MyBlu ENDS - Original
- Other: Altria MarkTen ENDS - Bold Classic
- Other: MLV PHIX ENDS - Original Tobacco
- Other: NJOY Daily EXTRA ENDS - Rich Tobacco
- Other: Altria Marlboro combustible cigarette - Red
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Christchurch, New Zealand, 8011
- Christchurch Clinical Studies Trust Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
|
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
48 days
|
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)
|
48 days
|
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.
|
48 days
|
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)
|
48 days
|
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
|
48 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
48 days
|
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. |
48 days
|
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.
|
48 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Concetta Carbonaro, JUUL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROT-00013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Use
-
University of VirginiaVirginia Foundation for Healthy YouthRecruitingTobacco Use | Electronic Cigarette Use | Tobacco Use CessationUnited States
-
Vanderbilt University Medical CenterCompletedTobacco Use | Tobacco Use Cessation
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Electronic Cigarette Use | Cigarette Use, ElectronicUnited States
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Electronic Cigarette Use | Cigarette Use, ElectronicUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditionsUnited States
-
British American Tobacco (Investments) LimitedCompletedTobacco Use | Tobacco SmokingUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco DependenceUnited States
-
Philip Morris Products S.A.CompletedSmoking | Tobacco Use | Tobacco SmokingUnited Kingdom
Clinical Trials on JUUL Virginia Tobacco flavored 5.0% ENDS
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Nicotine Dependence | Nicotine Dependence, CigarettesNew Zealand
-
Juul Labs, Inc.Rose Research Center, LLCCompletedTobacco Use | Tobacco Smoking | Nicotine Dependence, Other Tobacco ProductUnited States
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Electronic Cigarette Use | Cigarette Use, ElectronicUnited States
-
Juul Labs, Inc.CelerionCompletedTobacco Use | Smoking, Tobacco | Nicotine Dependence, Other Tobacco ProductUnited States
-
Juul Labs, Inc.Battelle Memorial Institute; Los Angeles Clinical TrialsCompletedElectronic Cigarette UseUnited States
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Nicotine Dependence | Nicotine Dependence, CigarettesUnited States
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Electronic Cigarette Use | Cigarette Use, ElectronicUnited States