Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Tobacco Smoking; Nicotine Dependence; Nicotine Dependence, Cigarettes
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Clinical Studies Trust Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

10

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Juul Labs, Inc.
• Investigators: Principal Investigator: Christopher Wynne, MD, Christchurch Clinical Studies Trust Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): July 26, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Nicotine; Electronic Nicotine Delivery System; Combustible Cigarettes
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: PROT-00008 / v2.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes