Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

Study Overview
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Brief Summary
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A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

Detailed Description
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E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhalation of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will provide an understanding of the levels of nicotine obtained with use of the company's 1.7% and 5% ENDS products.

Official Title
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A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based Electronic Nicotine Delivery System (ENDS Products), in Healthy Adult Smokers

Conditions
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Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking

Intervention / Treatment
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* Other: Tobacco flavored JUUL 1.7% ENDS
* Other: Tobacco flavored JUUL 5% ENDS
* Other: Mint flavored JUUL 1.7% ENDS
* Other: Mint flavored JUUL 5% ENDS
* Other: Fruit Medley flavored JUUL 1.7% ENDS
* Other: Fruit Medley flavored JUUL 5% ENDS
* Other: Crème brulee flavored JUUL 1.7% ENDS
* Other: Crème brulee flavored JUUL 5% ENDS
* Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
* Other: JUUL 5% ENDS 10 puffs vs. ad lib puffs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 to 60 years of age inclusive. Current smoker or e-cigarette user: Able to participate, and willing to give written informed consent and to comply with the ° study restrictions. Exclusion criteria: 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. Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator. Positive urine pregnancy test at screening or Assessment Days in female subjects of child bearing potential. Any clinically significant concomitant disease or conditions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobacco flavored JUUL 1.7% ENDS<br>Tobacco flavored JUUL 1.7% ENDS (10 puffs) | Other: Tobacco flavored JUUL 1.7% ENDS<br>* Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)<br>|
| Experimental: Tobacco flavored JUUL 5% ENDS<br>Tobacco flavored JUUL 5% ENDS (10 puffs) | Other: Tobacco flavored JUUL 5% ENDS<br>* Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)<br>|
| Experimental: Mint flavored JUUL 1.7% ENDS<br>Mint flavored JUUL 1.7% ENDS (10 puffs); | Other: Mint flavored JUUL 1.7% ENDS<br>* Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)<br>|
| Experimental: Mint flavored JUUL 5% ENDS<br>Mint flavored JUUL 5% ENDS (10 puffs) | Other: Mint flavored JUUL 5% ENDS<br>* Treatment with Mint flavored JUUL 5% ENDS(10 puffs)<br>|
| Experimental: Fruit Medley flavored JUUL 1.7% ENDS<br>Fruit Medley flavored JUUL 1.7% ENDS (10 puffs) | Other: Fruit Medley flavored JUUL 1.7% ENDS<br>* Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)<br>|
| Experimental: Fruit Medley flavored JUUL 5% ENDS<br>Fruit Medley flavored JUUL 5% ENDS (10 puffs) | Other: Fruit Medley flavored JUUL 5% ENDS<br>* Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)<br>|
| Experimental: Crème brulee flavored JUUL 1.7% ENDS<br>Crème brulee flavored JUUL 1.7% ENDS (10 puffs) | Other: Crème brulee flavored JUUL 1.7% ENDS<br>* Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)<br>|
| Experimental: Crème brulee flavored JUUL 5% ENDS<br>Crème brulee flavored JUUL 5% ENDS (10 puffs) | Other: Crème brulee flavored JUUL 5% ENDS<br>* Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)<br>|
| Experimental: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs<br>Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs | Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs<br>* Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs<br>|
| Experimental: JUUL 5% ENDS 10 puffs vs. ad lib puffs<br>Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs | Other: JUUL 5% ENDS 10 puffs vs. ad lib puffs<br>* Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax) | Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs). | 38 Days | 
| Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax) | Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs). | 38 Days | 
| Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour | Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs). | 38 Days | 
| Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine | Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs). | 38 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product. | Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product. | 38 Days | 
| To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users. | Measure of subjective product evaluation using the modified Product Evaluation Scale (mPES) Change in Evaluation; Scale: 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 (items 1, 2, 3, and 12); Psychological Reward (items 4 through 8); Aversion (items 9, 10, 16, and 18); and Relief (item 11, 13, 14, 15, and reversed for item 19) and single items 17 and 20 will be summarized. | 38 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine