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Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems

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ClinicalTrials.gov Identifier: NCT04123041
Recruitment Status : Completed
First Posted : October 10, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Juul Labs, Inc.

Brief Summary:
The purpose of this study is to estimate nicotine uptake and assess subjective effects during ad libitum use sessions of 4 flavors of JUUL ENDS (also referred to as nicotine salt pod system; NSPS) products (i.e., Virginia Tobacco, Mint, Menthol and Mango) with 2 different nicotine concentrations. Subjective effects will also be assessed to gain an understanding of the user's experience during and after JUUL ENDS product use to evaluate the abuse liability of the products. The subject population will consist of healthy adult, male and female smokers, 21 to 65 years of age.

Condition or disease Intervention/treatment Phase
Electronic Cigarette Use Tobacco Smoking Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: The study is open label; however, subjects will be masked to the percentage of nicotine in JUUL products.
Primary Purpose: Other
Official Title: A Randomized, Open-Label, Cross-Over Study to Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems With Multiple Flavors and Nicotine Concentrations, Usual Brand of Combustible Cigarettes, a Comparator E-Cigarette and Nicotine Gum in Adult Smokers
Actual Study Start Date : September 23, 2019
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019


Arm Intervention/treatment
Experimental: Virginia Tobacco
Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Virginia Tobacco ENDS, JUUL 3% Virginia Tobacco ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.
Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum

Experimental: Mint
Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Mint ENDS, JUUL 3% Mint ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.
Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum

Experimental: Menthol
Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Menthol ENDS, JUUL 3% Menthol ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.
Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum

Experimental: Mango
Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Mango ENDS, JUUL 3% Mango ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.
Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum




Primary Outcome Measures :
  1. Nicotine uptake [ Time Frame: 120 minutes ]
    Baseline-adjusted maximum plasma nicotine concentration [Cmax]

  2. Product liking as measured by the Product-Liking Questionnaire [ Time Frame: 60 minutes ]
    Maximum response to the Product-Liking Questionnaire (visual analog scale, range of "not at all" to "a great deal")


Secondary Outcome Measures :
  1. Nicotine uptake [ Time Frame: 120 minutes ]
    Time of the maximum post-baseline nicotine concentration

  2. Nicotine uptake [ Time Frame: 30 minutes ]
    Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 30 minutes

  3. Nicotine uptake [ Time Frame: 60 minutes ]
    Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 60 minutes

  4. Nicotine uptake [ Time Frame: 120 minutes ]
    Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 120 minutes

  5. The effects of nicotine exposure as measured by the Nicotine Withdrawal Questionnaire visual analog scale [ Time Frame: 60 minutes ]
    Maximum response to the Nicotine Withdrawal Questionnaire (visual analog scale, range "not at all" to "extremely")

  6. The effects of nicotine exposure as measured by the Product Direct Effects Questionnaire [ Time Frame: 60 minutes ]
    Maximum response to the Product Direct Effects Questionnaire (visual analog scale, range "not at all" to "extremely")

  7. Subjective product assessments as measured by the Modified Product Evaluation Scale [ Time Frame: 60 minutes ]
    Subjective product assessments as measured by responses to the Modified Product Evaluation Scale (scale range of 1 [not at all] to 7 [extremely])

  8. Likelihood of future product use as measured by the Future Intent to Use the Product Questionnaire [ Time Frame: 60 minutes ]
    Maximum response to the Future Intent to Use the Product Questionnaire (visual analog scale range of "definitely would not" to "definitely would")

  9. E-cigarette product use [ Time Frame: 5 minutes ]
    Change in mass of e-cigarette pods/cartridges

  10. Physiologic impact of product use as measured by blood pressure [ Time Frame: 60 minutes ]
    Systolic and diastolic pressures

  11. Physiologic impact of product use as measured by heart rate [ Time Frame: 60 minutes ]
    Heart rate

  12. Puff count during ad libitum (e-)cigarette use periods [ Time Frame: 5 minutes ]
    Number of puffs taken during ad libitum use session

  13. Safety and tolerability of short-term product use assessed by monitoring the incidence of product-use emergent adverse events [ Time Frame: 14 days ]
    Safety and tolerability will be assessed by monitoring the incidence of product-use emergent adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF).
  2. Adult, male or female smoker, 21 to 65 years of age, inclusive, at screening.
  3. Has been a smoker for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, quit attempt (prior to 30 days of screening), participation in a study where smoking was prohibited) during the 12 months prior to screening will be permitted at the discretion of the Investigator.
  4. Currently smokes an average of 10 or more king size or 100s manufactured combustible cigarettes per day (CPD; non-menthol or menthol), as reported at screening.
  5. Has a positive urine cotinine (≥200 ng/mL) at screening.
  6. Has an exhaled CO (carbon monoxide) >10 ppm at screening.
  7. A female subject of childbearing potential must have been using 1 of the following forms of contraception, and agree to continue using it through completion of the study: hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to check-in (Day -1); double barrier method (e.g., condom with spermicide, diaphragm with spermicide) at screening; intrauterine device for at least 3 months prior to check-in (Day -1); a partner who has been vasectomized for at least 6 months prior to check-in (Day -1); abstinence beginning at least 6 months prior to screening.
  8. A female subject of non-childbearing potential must be postmenopausal with amenorrhea for at least 1 year prior to check-in (Day -1) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal status or have undergone one of the following sterilization procedures at least 6 months prior to check-in (Day -1): hysteroscopic sterilization; bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy.
  9. Is willing to comply with the requirements of the study, including a willingness to use the study products during the study.

Exclusion Criteria:

  1. Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
  2. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of an investigator.
  3. Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
  4. Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to check-in (Day -1).
  5. Has a fever (>100.5°F) at screening or check-in (Day -1).
  6. Has a body mass index (BMI) >40.0 kg/m2 or <18.0 kg/m2 at screening.
  7. Has a history of drug or alcohol abuse within 24 months of check-in (Day -1), as determined by an investigator.
  8. Has or has a history of diabetes mellitus, asthma, or chronic obstructive pulmonary disease.
  9. Has used prescription anti-diabetic medication and/or insulin therapy within 12 months prior to screening.
  10. Has taken any medication for depression or asthma within 6 months prior to screening.
  11. Has a systolic blood pressure <90 or >150 mmHg, diastolic blood pressure <40 or >95 mmHg, or heart rate <40 or >99 bpm at screening.
  12. Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (nicotine, flavor, benzoic acid, propylene glycol and glycerol).
  13. Has an estimated creatinine clearance <70 mL/minute (using the Cockcroft-Gault equation) at screening.
  14. Has a positive urine screen for alcohol or drugs of abuse at screening or check-in (Day -1).
  15. If female, the subject is pregnant, has a positive pregnancy test at screening, is lactating, or intends to become pregnant during the time period from screening through the end of study.
  16. Has used medications known to interact with cytochrome P450 (CYP) 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to check-in (Day -1).
  17. Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 30 days prior to check-in (Day -1).
  18. Has any prior history of JUUL product use prior to screening.
  19. Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or bupropion (Zyban®) within 3 months prior to check-in (Day -1).
  20. Negative response (i.e., unwilling to use or unable to tolerate; e.g., experiences AEs (adverse events) during the product trial that will prevent the subjects from continuing to use the study products as judged by the investigator) to any of the JUUL products at screening.
  21. Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
  22. Is planning to quit smoking during the study or postponing (within 30 days of screening) a quit attempt in order to participate in the study.
  23. Has donated plasma within 7 days prior to check-in.
  24. Has donated blood or blood products (with the exception of plasma as noted above), had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to check-in (Day -1).
  25. Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to check-in (Day -1).
  26. Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee of the study site.
  27. Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee, shareholder, or is member of the board of directors of JUUL Labs, Inc.
  28. In the opinion of the Investigator, the subject should not participate in this study.
  29. Has previously taken part in, has been excluded or withdrawn from, or has completed this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123041


Locations
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United States, Kansas
Altasciences Clinical Kansas, Inc.
Kansas City, Kansas, United States, 66212
United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
Sponsors and Collaborators
Juul Labs, Inc.
Publications:
McNeill A [et al.] E-cigarettes: an evidence update. A report commissioned by Public Health England [Report]. - 2015.
USDHH US Department of Health and Human Services The Health Consequences of Smoking- 50 Years of Progress: A Report of the Surgeon General [Book] / ed. Health National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and. - 2014.

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Responsible Party: Juul Labs, Inc.
ClinicalTrials.gov Identifier: NCT04123041    
Other Study ID Numbers: PROT-00033
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juul Labs, Inc.:
Electronic Nicotine Delivery System
Combustible Cigarettes
Nicotine
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action