Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 26, 2018

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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).
  • 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).
  • 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).
  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Juul Labs, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christopher Wynne, MD, Principal Investigator, Christchurch Clinical Studies Trust Ltd

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