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

NCT04123041 | Completed

• 1 other identifier: PROT-00033
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 2

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.

Conditions

Electronic Cigarette Use; Tobacco Smoking

Keywords

Electronic Nicotine Delivery System; Combustible Cigarettes; Nicotine

Outcome Measures

Primary Outcomes (2)

• Nicotine uptake

  Baseline-adjusted maximum plasma nicotine concentration \[Cmax\]

  120 minutes

• Product liking as measured by the Product-Liking Questionnaire

  Maximum response to the Product-Liking Questionnaire (visual analog scale, range of "not at all" to "a great deal")

  60 minutes

Secondary Outcomes (13)

• Nicotine uptake

  120 minutes

• Nicotine uptake

  30 minutes

• Nicotine uptake

  60 minutes

• Nicotine uptake

  120 minutes

• The effects of nicotine exposure as measured by the Nicotine Withdrawal Questionnaire visual analog scale

  60 minutes

Study Arms (4)

Virginia Tobacco

EXPERIMENTAL

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

Mint

EXPERIMENTAL

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

Menthol

EXPERIMENTAL

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

Mango

EXPERIMENTAL

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

Interventions

JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum OTHER

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; Menthol; Mint; Virginia Tobacco

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF).
• Adult, male or female smoker, 21 to 65 years of age, inclusive, at screening.
• 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.
• 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.
• Has a positive urine cotinine (≥200 ng/mL) at screening.
• Has an exhaled CO (carbon monoxide) \>10 ppm at screening.
• 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.
• 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.
• Is willing to comply with the requirements of the study, including a willingness to use the study products during the study.

You may not qualify if:

• 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.
• 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.
• Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
• Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to check-in (Day -1).
• Has a fever (\>100.5°F) at screening or check-in (Day -1).
• 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 (Day -1), as determined by an investigator.
• Has or has a history of diabetes mellitus, asthma, or chronic obstructive pulmonary disease.
• Has used prescription anti-diabetic medication and/or insulin therapy within 12 months prior to screening.
• Has taken any medication for depression or asthma within 6 months prior to screening.
• 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.
• 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).
• Has an estimated creatinine clearance \<70 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 (Day -1).
• 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.

Sponsors & Collaborators

• Juul Labs, Inc.: lead

Study Sites (2)

Altasciences Clinical Kansas, Inc.

Kansas City, Kansas, 66212, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Related Publications (10)

• 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.

  PMID: 28056007 BACKGROUND

• 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.

  PMID: 27401980 BACKGROUND

• 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.

  PMID: 28813211 BACKGROUND

• 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.

  PMID: 23239843 BACKGROUND

• 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.

  PMID: 25607446 BACKGROUND

• McNeill A [et al.] E-cigarettes: an evidence update. A report commissioned by Public Health England [Report]. - 2015.

  BACKGROUND

• 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.

  PMID: 24814944 BACKGROUND

• Tanner JA, Tyndale RF. Variation in CYP2A6 Activity and Personalized Medicine. J Pers Med. 2017 Dec 1;7(4):18. doi: 10.3390/jpm7040018.

  PMID: 29194389 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30408019 BACKGROUND

MeSH Terms

Conditions

Vaping; Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is open label; however, subjects will be masked to the percentage of nicotine in JUUL products.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 10, 2019
• Study Start: September 23, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)