Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems
NCT ID: NCT04123041
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2019-09-23
2019-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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.
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
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.
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
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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
65 Years
ALL
Yes
Sponsors
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Juul Labs, Inc.
INDUSTRY
Responsible Party
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Locations
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Altasciences Clinical Kansas, Inc.
Kansas City, Kansas, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Countries
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References
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Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting Smoking Among Adults - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Jan 6;65(52):1457-1464. doi: 10.15585/mmwr.mm6552a1.
D'Ruiz CD, Graff DW, Robinson E. Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health. 2016 Jul 11;16:543. doi: 10.1186/s12889-016-3236-1.
Gottlieb S, Zeller M. A Nicotine-Focused Framework for Public Health. N Engl J Med. 2017 Sep 21;377(12):1111-1114. doi: 10.1056/NEJMp1707409. Epub 2017 Aug 16. No abstract available.
Hatsukami DK, Zhang Y, O'Connor RJ, Severson HH. Subjective responses to oral tobacco products: scale validation. Nicotine Tob Res. 2013 Jul;15(7):1259-64. doi: 10.1093/ntr/nts265. Epub 2012 Dec 13.
Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH. Hidden formaldehyde in e-cigarette aerosols. N Engl J Med. 2015 Jan 22;372(4):392-4. doi: 10.1056/NEJMc1413069. No abstract available.
McNeill A [et al.] E-cigarettes: an evidence update. A report commissioned by Public Health England [Report]. - 2015.
Polosa R, Morjaria J, Caponnetto P, Caruso M, Strano S, Battaglia E, Russo C. Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: evidence for harm reversal. Int J Environ Res Public Health. 2014 May 8;11(5):4965-77. doi: 10.3390/ijerph110504965.
Tanner JA, Tyndale RF. Variation in CYP2A6 Activity and Personalized Medicine. J Pers Med. 2017 Dec 1;7(4):18. doi: 10.3390/jpm7040018.
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.
Wang TW, Asman K, Gentzke AS, Cullen KA, Holder-Hayes E, Reyes-Guzman C, Jamal A, Neff L, King BA. Tobacco Product Use Among Adults - United States, 2017. MMWR Morb Mortal Wkly Rep. 2018 Nov 9;67(44):1225-1232. doi: 10.15585/mmwr.mm6744a2.
Other Identifiers
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PROT-00033
Identifier Type: -
Identifier Source: org_study_id
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