Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593239
• Other study ID #: PROT-00008 / v2.1
• Status: Completed
• Phase: N/A
• Start date: June 29, 2018
• Est. completion date: July 26, 2018

Study information

• Verified date: June 2021
• Source: Juul Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Nicotine Dependence, Cigarettes
• Tobacco Smoking
• Tobacco Use
• Tobacco Use Disorder

Intervention

Other:
• Tobacco flavored JUUL 1.7% ENDS
Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)
• Tobacco flavored JUUL 5% ENDS
Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)
• Mint flavored JUUL 1.7% ENDS
Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)
• Mint flavored JUUL 5% ENDS
Treatment with Mint flavored JUUL 5% ENDS(10 puffs)
• Fruit Medley flavored JUUL 1.7% ENDS
Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)
• Fruit Medley flavored JUUL 5% ENDS
Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)
• Crème brulee flavored JUUL 1.7% ENDS
Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)
• Crème brulee flavored JUUL 5% ENDS
Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)
• JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs
• JUUL 5% ENDS 10 puffs vs. ad lib puffs
Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs

Locations

Country	Name	City	State
New Zealand	Christchurch Clinical Studies Trust Ltd	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Juul Labs, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

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