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Completed

NCT Number: NCT03593239

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 ENDS Products, in Healthy Adult Smokers.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Mental Disorders Nicotine Dependence, Cigarettes Smoking Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder Vaping

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christchurch Clinical Studies Trust Ltd

Christchurch, 8011, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tobacco flavored JUUL 1.7% ENDS

Other

Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Tobacco flavored JUUL 5% ENDS

Other

Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)

Mint flavored JUUL 1.7% ENDS

Other

Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)

Mint flavored JUUL 5% ENDS

Other

Treatment with Mint flavored JUUL 5% ENDS(10 puffs)

Fruit Medley flavored JUUL 1.7% ENDS

Other

Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)

Fruit Medley flavored JUUL 5% ENDS

Other

Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)

Crème brulee flavored JUUL 1.7% ENDS

Other

Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)

Crème brulee flavored JUUL 5% ENDS

Other

Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

Other

Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs

JUUL 5% ENDS 10 puffs vs. ad lib puffs

Other

Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs

Primary outcomes

  1. Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)

    Time frame: 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).

  2. Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)

    Time frame: 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).

  3. Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour

    Time frame: 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).

  4. Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine

    Time frame: 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 outcomes

  1. Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.

    Time frame: 38 Days

    Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.

  2. To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Juul Labs, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2018
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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