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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco flavored JUUL 1.7% ENDS | Experimental | Tobacco flavored JUUL 1.7% ENDS (10 puffs) |
|
| Tobacco flavored JUUL 5% ENDS | Experimental | Tobacco flavored JUUL 5% ENDS (10 puffs) |
|
| Mint flavored JUUL 1.7% ENDS | Experimental | Mint flavored JUUL 1.7% ENDS (10 puffs); |
|
| Mint flavored JUUL 5% ENDS | Experimental | Mint flavored JUUL 5% ENDS (10 puffs) |
|
| Fruit Medley flavored JUUL 1.7% ENDS | Experimental | Fruit Medley flavored JUUL 1.7% ENDS (10 puffs) |
|
| Fruit Medley flavored JUUL 5% ENDS | Experimental | Fruit Medley flavored JUUL 5% ENDS (10 puffs) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco flavored JUUL 1.7% ENDS | Other | Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs) |
|
| 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). |
| 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Wynne, MD | Christchurch Clinical Studies Trust Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch Clinical Studies Trust Ltd | Christchurch | 8011 | New Zealand |
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| Crème brulee flavored JUUL 1.7% ENDS | Experimental | Crème brulee flavored JUUL 1.7% ENDS (10 puffs) |
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| Crème brulee flavored JUUL 5% ENDS | Experimental | Crème brulee flavored JUUL 5% ENDS (10 puffs) |
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| JUUL 1.7% ENDS 10 puffs vs. ad lib puffs | Experimental | Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs |
|
| JUUL 5% ENDS 10 puffs vs. ad lib puffs | Experimental | Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs |
|
| Tobacco flavored JUUL 5% ENDS | Other | Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs) |
|
| Mint flavored JUUL 1.7% ENDS | Other | Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs) |
|
| Mint flavored JUUL 5% ENDS | Other | Treatment with Mint flavored JUUL 5% ENDS(10 puffs) |
|
| Fruit Medley flavored JUUL 1.7% ENDS | Other | Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs) |
|
| Fruit Medley flavored JUUL 5% ENDS | Other | Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs) |
|
| Crème brulee flavored JUUL 1.7% ENDS | Other | Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs) |
|
| Crème brulee flavored JUUL 5% ENDS | Other | Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs) |
|
| JUUL 1.7% ENDS 10 puffs vs. ad lib puffs | Other | Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs |
|
| JUUL 5% ENDS 10 puffs vs. ad lib puffs | Other | Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs |
|
| 38 Days |
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 |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D012907 | Smoking |
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