Nicotine Dependence Clinical Trial
Official title:
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
Verified date | June 2021 |
Source | Juul Labs, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 26, 2018 |
Est. primary completion date | July 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
New Zealand | Christchurch Clinical Studies Trust Ltd | Christchurch |
Lead Sponsor | Collaborator |
---|---|
Juul Labs, Inc. |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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