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Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

Primary Purpose

Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Tobacco flavored JUUL 1.7% ENDS
Tobacco flavored JUUL 5% ENDS
Mint flavored JUUL 1.7% ENDS
Mint flavored JUUL 5% ENDS
Fruit Medley flavored JUUL 1.7% ENDS
Fruit Medley flavored JUUL 5% ENDS
Crème brulee flavored JUUL 1.7% ENDS
Crème brulee flavored JUUL 5% ENDS
JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
JUUL 5% ENDS 10 puffs vs. ad lib puffs
Sponsored by
Juul Labs, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nicotine Dependence focused on measuring Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Christchurch Clinical Studies Trust Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Tobacco flavored JUUL 1.7% ENDS

Tobacco flavored JUUL 5% ENDS

Mint flavored JUUL 1.7% ENDS

Mint flavored JUUL 5% ENDS

Fruit Medley flavored JUUL 1.7% ENDS

Fruit Medley flavored JUUL 5% ENDS

Crème brulee flavored JUUL 1.7% ENDS

Crème brulee flavored JUUL 5% ENDS

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

JUUL 5% ENDS 10 puffs vs. ad lib puffs

Arm Description

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)

Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs

Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 1, 2018
Last Updated
June 15, 2021
Sponsor
Juul Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03593239
Brief Title
Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juul Labs, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
Keywords
Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tobacco flavored JUUL 1.7% ENDS
Arm Type
Experimental
Arm Description
Tobacco flavored JUUL 1.7% ENDS (10 puffs)
Arm Title
Tobacco flavored JUUL 5% ENDS
Arm Type
Experimental
Arm Description
Tobacco flavored JUUL 5% ENDS (10 puffs)
Arm Title
Mint flavored JUUL 1.7% ENDS
Arm Type
Experimental
Arm Description
Mint flavored JUUL 1.7% ENDS (10 puffs);
Arm Title
Mint flavored JUUL 5% ENDS
Arm Type
Experimental
Arm Description
Mint flavored JUUL 5% ENDS (10 puffs)
Arm Title
Fruit Medley flavored JUUL 1.7% ENDS
Arm Type
Experimental
Arm Description
Fruit Medley flavored JUUL 1.7% ENDS (10 puffs)
Arm Title
Fruit Medley flavored JUUL 5% ENDS
Arm Type
Experimental
Arm Description
Fruit Medley flavored JUUL 5% ENDS (10 puffs)
Arm Title
Crème brulee flavored JUUL 1.7% ENDS
Arm Type
Experimental
Arm Description
Crème brulee flavored JUUL 1.7% ENDS (10 puffs)
Arm Title
Crème brulee flavored JUUL 5% ENDS
Arm Type
Experimental
Arm Description
Crème brulee flavored JUUL 5% ENDS (10 puffs)
Arm Title
JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
Arm Type
Experimental
Arm Description
Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs
Arm Title
JUUL 5% ENDS 10 puffs vs. ad lib puffs
Arm Type
Experimental
Arm Description
Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs
Intervention Type
Other
Intervention Name(s)
Tobacco flavored JUUL 1.7% ENDS
Intervention Description
Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)
Intervention Type
Other
Intervention Name(s)
Tobacco flavored JUUL 5% ENDS
Intervention Description
Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)
Intervention Type
Other
Intervention Name(s)
Mint flavored JUUL 1.7% ENDS
Intervention Description
Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)
Intervention Type
Other
Intervention Name(s)
Mint flavored JUUL 5% ENDS
Intervention Description
Treatment with Mint flavored JUUL 5% ENDS(10 puffs)
Intervention Type
Other
Intervention Name(s)
Fruit Medley flavored JUUL 1.7% ENDS
Intervention Description
Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)
Intervention Type
Other
Intervention Name(s)
Fruit Medley flavored JUUL 5% ENDS
Intervention Description
Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)
Intervention Type
Other
Intervention Name(s)
Crème brulee flavored JUUL 1.7% ENDS
Intervention Description
Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)
Intervention Type
Other
Intervention Name(s)
Crème brulee flavored JUUL 5% ENDS
Intervention Description
Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)
Intervention Type
Other
Intervention Name(s)
JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
Intervention Description
Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs
Intervention Type
Other
Intervention Name(s)
JUUL 5% ENDS 10 puffs vs. ad lib puffs
Intervention Description
Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs
Primary Outcome Measure Information:
Title
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)
Description
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).
Time Frame
38 Days
Title
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)
Description
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).
Time Frame
38 Days
Title
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour
Description
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).
Time Frame
38 Days
Title
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine
Description
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).
Time Frame
38 Days
Secondary Outcome Measure Information:
Title
Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
Description
Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
Time Frame
38 Days
Title
To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.
Description
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.
Time Frame
38 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Wynne, MD
Organizational Affiliation
Christchurch Clinical Studies Trust Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christchurch Clinical Studies Trust Ltd
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

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