Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

Not Applicable

Completed

• Conditions: Nicotine Dependence; Tobacco Use; Tobacco Smoking; Nicotine Dependence, Cigarettes
• Interventions: Other: Mint flavored JUUL 1.7% ENDS; Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs; Other: Tobacco flavored JUUL 5% ENDS; Other: Crème brulee flavored JUUL 1.7% ENDS; Other: Mint flavored JUUL 5% ENDS; Other: Crème brulee flavored JUUL 5% ENDS; Other: Fruit Medley flavored JUUL 1.7% ENDS; Other: Fruit Medley flavored JUUL 5% ENDS; Other: Tobacco flavored JUUL 1.7% ENDS; Other: JUUL 5% ENDS 10 puffs vs. ad lib puffs

• Registration Number: NCT03593239
• Lead Sponsor: Juul Labs, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-06-01
• Study Start: 2018-06-29
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-20
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mint flavored JUUL 1.7% ENDS	Mint flavored JUUL 1.7% ENDS	Mint flavored JUUL 1.7% ENDS (10 puffs);
JUUL 1.7% ENDS 10 puffs vs. ad lib puffs	JUUL 1.7% ENDS 10 puffs vs. ad lib puffs	Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs
Tobacco flavored JUUL 5% ENDS	Tobacco flavored JUUL 5% ENDS	Tobacco flavored JUUL 5% ENDS (10 puffs)
Crème brulee flavored JUUL 1.7% ENDS	Crème brulee flavored JUUL 1.7% ENDS	Crème brulee flavored JUUL 1.7% ENDS (10 puffs)
Mint flavored JUUL 5% ENDS	Mint flavored JUUL 5% ENDS	Mint flavored JUUL 5% ENDS (10 puffs)
Crème brulee flavored JUUL 5% ENDS	Crème brulee flavored JUUL 5% ENDS	Crème brulee flavored JUUL 5% ENDS (10 puffs)
Fruit Medley flavored JUUL 1.7% ENDS	Fruit Medley flavored JUUL 1.7% ENDS	Fruit Medley flavored JUUL 1.7% ENDS (10 puffs)
Fruit Medley flavored JUUL 5% ENDS	Fruit Medley flavored JUUL 5% ENDS	Fruit Medley flavored JUUL 5% ENDS (10 puffs)
Tobacco flavored JUUL 1.7% ENDS	Tobacco flavored JUUL 1.7% ENDS	Tobacco flavored JUUL 1.7% ENDS (10 puffs)
JUUL 5% ENDS 10 puffs vs. ad lib puffs	JUUL 5% ENDS 10 puffs vs. ad lib puffs	Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs

Primary Outcome Measures

Name	Time	Method
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)	38 Days	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).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine	38 Days	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).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)	38 Days	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).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour	38 Days	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).

Secondary Outcome Measures

Name	Time	Method
Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.	38 Days	Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.	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.

Trial Locations

Locations (1)

Christchurch Clinical Studies Trust Ltd; 🇳🇿 Christchurch, New Zealand