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Electronic Cigarette UseNCT04123041

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

A study testing JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum in people with Electronic Cigarette Use and Tobacco Smoking, run by Juul Labs, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Electronic Cigarette Use, Tobacco Smoking
What is being tested?
JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
2 sitesUnited States
Study dates
23 Sep 2019to 18 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.
  • 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).
  • 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).
  • Has any prior history of JUUL product use prior to screening.
  • 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).
  • 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.
  • 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 (within 30 days of screening) 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 (Day -1).
  • 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).
  • 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.
  • In the opinion of the Investigator, the subject should not participate in this study.
  • Has previously taken part in, has been excluded or withdrawn from, or has completed this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Altasciences Clinical Kansas, Inc.

    Kansas City, Kansas, 66212

  • Central Kentucky Research Associates

    Lexington, Kentucky, 40509

Other trials in United States

About this study

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

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.

Being tested
JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
Keywords
Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
Medical subject headings
Vaping, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gumOther

    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

Study groups in NCT04123041
Study groupRoleWhat they receive
Virginia TobaccoExperimentalSubjects 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.
Receives: Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
MintExperimentalSubjects 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.
Receives: Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
MentholExperimentalSubjects 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.
Receives: Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
MangoExperimentalSubjects 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.
Receives: Other: JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nicotine uptake

    Baseline-adjusted maximum plasma nicotine concentration [Cmax]

    Measured: 120 minutes

  2. 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")

    Measured: 60 minutes

Secondary outcomes (13)

  1. Nicotine uptake

    Time of the maximum post-baseline nicotine concentration

    Measured: 120 minutes

  2. Nicotine uptake

    Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 30 minutes

    Measured: 30 minutes

  3. Nicotine uptake

    Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 60 minutes

    Measured: 60 minutes

  4. Nicotine uptake

    Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 120 minutes

    Measured: 120 minutes

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

    Maximum response to the Nicotine Withdrawal Questionnaire (visual analog scale, range "not at all" to "extremely")

    Measured: 60 minutes

  6. The effects of nicotine exposure as measured by the Product Direct Effects Questionnaire

    Maximum response to the Product Direct Effects Questionnaire (visual analog scale, range "not at all" to "extremely")

    Measured: 60 minutes

  7. Subjective product assessments as measured by the Modified Product Evaluation Scale

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

    Measured: 60 minutes

  8. Likelihood of future product use as measured by the Future Intent to Use the Product Questionnaire

    Maximum response to the Future Intent to Use the Product Questionnaire (visual analog scale range of "definitely would not" to "definitely would")

    Measured: 60 minutes

  9. E-cigarette product use

    Change in mass of e-cigarette pods/cartridges

    Measured: 5 minutes

  10. Physiologic impact of product use as measured by blood pressure

    Systolic and diastolic pressures

    Measured: 60 minutes

  11. Physiologic impact of product use as measured by heart rate

    Heart rate

    Measured: 60 minutes

  12. Puff count during ad libitum (e-)cigarette use periods

    Number of puffs taken during ad libitum use session

    Measured: 5 minutes

  13. Safety and tolerability of short-term product use assessed by monitoring the incidence of product-use emergent adverse events

    Safety and tolerability will be assessed by monitoring the incidence of product-use emergent adverse events.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start23 Sep 2019
  3. Primary completion18 Dec 2019
  4. Study completion18 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04123041
Sponsor's protocol ID
PROT-00033
Status last verified
Feb 2020
First submitted
25 Sep 2019
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28056007

  • 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.

    PubMed 27401980

  • 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.

    PubMed 28813211

  • 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.

    PubMed 23239843

  • 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.

    PubMed 25607446

  • 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.

    PubMed 24814944

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

    PubMed 29194389

  • 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.

    PubMed 30408019

Questions about this trial

What is this clinical trial studying?

A study testing JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum in people with Electronic Cigarette Use and Tobacco Smoking, run by Juul Labs, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nicotine uptake (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04123041, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.

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