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United States Pre-Market Tobacco Application Pharmacokinetics (US-PMTA-PK)

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ClinicalTrials.gov Identifier: NCT03719391
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Juul Labs, Inc.

Brief Summary:
A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers

Condition or disease Intervention/treatment Phase
Nicotine Dependence Nicotine Dependence, Cigarettes Tobacco Use Tobacco Smoking Device: Virginia Tobacco flavored JUUL 5% ENDS Device: Cool Mint flavored JUUL 5% ENDS Device: Mango flavored JUUL 5% ENDS Device: Creme Brulee flavored JUUL 5% ENDS Device: VUSE Solo e-cigarette Other: Nicorette White Ice Mint 4mg nicotine polacrilex gum Device: Usual Brand combustible cigarette Not Applicable

Detailed Description:
E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhaltion 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 assess nicotine uptake during a 10-puff controlled and a 5-minute ad libitum use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, Open-Label, Cross-Over
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers
Actual Study Start Date : October 19, 2018
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: JUUL 5% Virginia Tobacco ENDS
Treatment with JUUL Virginia Tobacco flavored 5.0% ENDS product.
Device: Virginia Tobacco flavored JUUL 5% ENDS
Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).
Other Name: JUUL

Experimental: JUUL 5% Cool Mint ENDS
Treatment with JUUL Cool Mint flavored 5.0% ENDS product.
Device: Cool Mint flavored JUUL 5% ENDS
Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).
Other Name: JUUL

Experimental: JUUL 5% Mango ENDS
Treatment with JUUL Mango flavored 5.0% ENDS product.
Device: Mango flavored JUUL 5% ENDS
Treatment with Mango flavored JUUL 5% ENDS (10 puffs).
Other Name: JUUL

Experimental: JUUL 5% Creme Brulee ENDS
Treatment with JUUL Creme Brulee flavored 5.0% ENDS product.
Device: Creme Brulee flavored JUUL 5% ENDS
Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).
Other Name: JUUL

Active Comparator: VUSE Solo e-cigarette
Treatment with VUSE Solo Original with 4.8% nicotine product.
Device: VUSE Solo e-cigarette
Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).
Other Name: VUSE

Active Comparator: Nicotine Gum
Treatment with nicorette white ice mint 4mg nicotine polacrilex gum product.
Other: Nicorette White Ice Mint 4mg nicotine polacrilex gum
Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method)
Other Name: Nicotine Gum

Active Comparator: Usual Brand Combustible Cigarette
Treatment with usual brand combustible cigarette.
Device: Usual Brand combustible cigarette
Treatment with usual brand cigarette (10 puffs).




Primary Outcome Measures :
  1. To assess nicotine uptake during a 10-puff controlled use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum. [ Time Frame: 7 days ]
    Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. Baseline adjustments to the (non-adjusted) PK endpoints will also be presented.


Secondary Outcome Measures :
  1. To assess exhaled carbon monoxide [CO] following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum [ Time Frame: 7 Days ]
    Exhaled CO levels will be measured using a Bedfont Micro+ Smokerlyzer or similar device and levels at Screening and after product use will be assessed.

  2. To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using the "modified Product Evaluation Scale (mPES)" [ Time Frame: 7 Days ]

    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.


  3. To assess blood pressure following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum. [ Time Frame: 7 Days ]
  4. To assess heart rate following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum. [ Time Frame: 7 Days ]
  5. To assess the safety and tolerability of short-term use of four JUUL 5% ENDS. [ Time Frame: 7 Days ]
    Number of participants with Adverse Events associated with use of JUUL 5% Device will be described by individual listings and frequency tables.

  6. To characterize product use of four JUUL 5% ENDS during controlled use sessions. [ Time Frame: 7 Days ]
    All product use data will be summarized using descriptive statistics. The difference in weight pre- and post- product use of each JUUL product and comparator e-cigarettes will be summarized.

  7. To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Intent to Use Again Questionnaire. [ Time Frame: 7 Days ]
    The Intent to Use Again questionnaire will be assessed using a 100 mm bipolar VAS

  8. To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Nicotine Withdrawal Questionnaire. [ Time Frame: 7 Days ]
    The nicotine withdrawal will be assessed using a 100mm visual analog scale (VAS)

  9. To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Direct Effect Questionnaire. [ Time Frame: 7 Days ]
    Product direct effect will be assessed using a 100 mm VAS

  10. To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Liking Questionnaire. [ Time Frame: 7 Days ]
    Product liking will be assessed using a 100 mm VAS



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:

  • Healthy, adult, male or female smoker, 21 to 65 years of age, inclusive
  • 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, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the PI.
  • Currently smokes an average of 10 or more king size or 100s manufactured combustible CPD, as reported at Screening.
  • Has a positive urine cotinine (≥ 500 ng/mL) at Screening
  • Has an exhaled CO > 12 ppm at Screening.
  • Is willing to comply with the requirements of the study, including a willingness to use the study products during the study.

Exclusion Criteria:

  • 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 PI, would jeopardize the safety of the subject or impact the validity of the study results.
  • Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI.
  • Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
  • Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Check-in.
  • Has a fever (> 100.5°F) at Screening or Check-in.
  • Has a body mass index (BMI) > 40.0 kg/m2 or < 18.0 kg/m2 at Screening.
  • Has a history of drug or alcohol abuse within 24 months of Check-in, as determined by the PI.
  • Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease.
  • Has a systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 40 mmHg or > 95 mmHg, or heart rate < 40 bpm or > 99 bpm at Screening.
  • Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (benzoic acid, propylene glycol and glycerol).
  • Has an estimated creatinine clearance < 80 mL/minute (using the Cockcroft-Gault equation) at Screening.
  • Has a positive urine screen for alcohol or drugs of abuse at Screening or Check-in.
  • 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.
  • Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Check-in.
  • Has a prior history of JUUL product use prior to Screening
  • Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Check-in.
  • Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
  • Is planning to quit smoking during the study or postponing a quit attempt in order to participate in the study.
  • Has donated plasma within 7 days prior to Check-in.
  • 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.
  • Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Check-in.
  • Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee of the study site.
  • 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.
  • Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected at least 1 year prior to Screening.

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): NCT03719391


Locations
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United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Juul Labs, Inc.

Publications:
McNeill A et al. E-cigarettes: An Evidence Update. A report commissioned by Public Health England. Available at: https://www.gov.uk/government/uploads/system/uploads/ attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_ Public_Health_England_FINAL.pdf (Aug 2015).
HIPAA Privacy Rule. Information for Researchers. De-identifying Protected Health Information Under the Privacy Rule. U.S. Department of Health and Human Services. NIH (Feb 2007). Available at: http://privacyruleandresearch.nih.gov/pr_08.asp#8a. Last accessed 31-Jul-2017.

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Responsible Party: Juul Labs, Inc.
ClinicalTrials.gov Identifier: NCT03719391     History of Changes
Other Study ID Numbers: PROT-00009
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Juul Labs, Inc.:
Electronic Nicotine Delivery System
Combustible Cigarettes
Nicotine

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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